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Study in Healthy Recreational Polydrug Users to Measure the Abuse Potential of TC-5214 (TC-5214)

Primary Purpose

Drug Abuse, Healthy

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
TC-5214
TC-5214 Placebo
Ketamine
Phentermine
TC-5214
TC-5214
Phentermine
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Drug Abuse focused on measuring Phase I, healthy recreational polydrug users, abuse liability, TC-5214, Single dose crossover study to evaluate the abuse potential of TC-5214

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Current recreational polydrug users with experience with at least 2 drug classes of abuse.
  • At least 10 lifetime uses of stimulants drugs (eg, amphetamine, cocaine, methamphetamine) and 10 lifetime occasions of recreational use of psychedelic drugs (eg, cannabis, ketamine, dextromethorphan, PCP, MDMA [ecstasy], LSD, mesacline, or psilocybin).
  • Recreational use of other classes of drugs is permitted, including opioids (eg, codeine, morphine, or heroin), minor tranquilizers, or sedatives (eg, benzodiazepines or barbiturates).
  • Male or female volunteers aged 18 to 55, inclusive with a body mass index (BMI) within the range of 19.0 to 33.0 kg/m2, inclusive, and a minimum weight of 50.0 kg at screening.
  • Must pass qualification phase eligibility criteria.

Exclusion Criteria:

  • Self-reported history of drug or alcohol dependence (except caffeine) in the past 12 months, including subjects who have ever been in a drug rehabilitation program (other than treatment for smoking cessation).
  • Unwillingness or inability to abstain from recreational drug use for the duration of the study from screening until follow-up.
  • Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at screening.
  • Any significant unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or any other medical conditions that might confound the study or put the volunteer at greater risk during study participation.
  • Currently smoking more than 20 cigarettes (or 2 cigars) per day, and/or unwillingness to abstain from smoking for durations of at least 12 hours.
  • Use of tobacco cessation product within 1 month (eg, nicotine substitution products, bupropion, etc).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm 9

    Arm 10

    Arm 11

    Arm 12

    Arm 13

    Arm 14

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Crossover Treatment Sequence 1

    Crossover Treatment Sequence 2

    Crossover Treatment Sequence 3

    Crossover Treatment Sequence 4

    Crossover Treatment Sequence 5

    Crossover Treatment Sequence 6

    Crossover Treatment Sequence 7

    Crossover Treatment Sequence 8

    Crossover Treatment Sequence 9

    Crossover Treatment Sequence 10

    Crossover Treatment Sequence 11

    Crossover Treatment Sequence 12

    Crossover Treatment Sequence 13

    Crossover Treatment Sequence 14

    Arm Description

    Period 1: Placebo, Period 2: Phentermine 45 mg, Period 3: Phentermine 90 mg, Period 4: Ketamine 100 mg, Period 5: TC-5214 2 mg, Period 6: TC-5214 8 mg, Period 7: TC-5214 16 mg

    Period 1: Phentermine 45 mg, Period 2: Ketamine 100 mg , Period 3: Placebo, Period 4: TC-5214 8 mg , Period 5: Phentermine 90 mg, Period 6: TC-5214 16 mg, Period 7: TC-5214 2 mg

    Period 1: Ketamine 100 mg, Period 2: TC-5214 8 mg, Period 3: Phentermine 45 mg, Period 4: TC-5214 16 mg, Period 5: Placebo, Period 6: TC-5214 2 mg, Period 7: Phentermine 90 mg

    Period 1: TC-5214 8 mg, Period 2: TC-5214 16 mg, Period 3: Ketamine 100 mg, Period 4: TC-5214 2 mg, Period 5: Phentermine 45 mg , Period 6: Phentermine 90 mg, Period 7: Placebo

    Period 1: TC-5214 16 mg, Period 2: TC-5214 2 mg, Period 3: TC-5214 8 mg, Period 4: Phentermine 90 mg, Period 5: Ketamine 100 mg, Period 6: Placebo , Period 7: Phentermine 45 mg

    Period 1: TC-5214 2 mg, Period 2: Phentermine 90 mg, Period 3: TC-5214 16 mg, Period 4: Placebo, Period 5: TC-5214 8 mg, Period 6:Phentermine 45 mg , Period 7: Ketamine 100 mg

    Period 1: Phentermine 90 mg, Period 2: Placebo, Period 3: TC-5214 2 mg, Period 4: Phentermine 45 mg, Period 5: TC-5214 16 mg, Period 6: Ketamine 100 mg, Period 7: TC-5214 8 mg

    Period 1: TC-5214 16 mg, Period 2: TC-5214 8 mg, Period 3: TC-5214 2 mg, Period 4: Ketamine 100 mg, Period 5: Phentermine 90 mg, Period 6: Phentermine 45 mg, Period 7: Placebo

    Period 1: TC-5214 2 mg, Period 2: TC-5214 16 mg, Period 3: Phentermine 90 mg, Period 4: TC-5214 8 mg, Period 5: Placebo, Period 6: Ketamine 100 mg, Period 7: Phentermine 45 mg

    Period 1: Phentermine 90 mg, Period 2: TC-5214 2 mg, Period 3: Placebo, Period 4: TC-5214 16 mg Ketamine 100 mg, Period 5: Phentermine 45 mg, Period 6: TC-5214 8 mg, Period 7: TC-5214 2 mg

    Period 1: Placebo, Period 2: Phentermine 90 mg, Period 3:Phentermine 45 mg, Period 4: TC-5214 2 mg, Period 5: Ketamine 100 mg, Period 6: TC-5214 16 mg, Period 7: TC-5214 8 mg

    Period 1: Phentermine 45 mg, Period 2: Placebo, Period 3: Ketamine 100 mg, Period 4:Phentermine 90 mg, Period 5: TC-5214 8 mg, Period 6: TC-5214 2 mg, Period 7: TC-5214 16 mg

    Period 1: Ketamine 100 mg, Period 2: Phentermine 45 mg, Period 3: TC-5214 8 mg, Period 4: Placebo, Period 5: TC-5214 16 mg, Period 6: Phentermine 90 mg, Period 7: TC-5214 2 mg

    Period 1: TC-5214 8 mg, Period 2: Ketamine 100 mg, Period 3: TC-5214 16 mg, Period 4: Phentermine 45 mg, Period 5: TC-5214 2 mg, Period 6: Placebo, Period 7: Phentermine 90 mg

    Outcomes

    Primary Outcome Measures

    Momentary Drug Liking VAS maximum effect (Emax)
    Visual analogue scale from 0 to 100 mm. The statement put is: "At this moment, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking". The maximum value recorded is chosen.

    Secondary Outcome Measures

    Momentary Drug Liking VAS minimum effect (Emin)
    Visual analogue scale from 0 to 100 mm. The statement put is: "At this moment, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking" The minimum value recorded is chosen.
    Drug Liking VAS time-weighted mean (TWmean)
    Visual analogue scale from 0 to 100 mm. The statement put is: "At this moment, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking". Time weighted average score is calculated.
    Overall Drug Liking VAS maximum effect ( Emax)
    Visual analogue scale from 0 to 100 mm. The statement put is: "Overall, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking". The maximum value recorded is chosen.
    Overall Drug Liking VAS (Emin)
    Visual analogue scale from 0 to 100 mm. The statement put is: "Overall, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking". The minimum value recorded is chosen
    Overall Drug Liking VAS 10-hour mean score
    Visual analogue scale from 0 to 100 mm. The statement put is: "Overall, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking". The mean value is calculated.
    Overall Drug Liking VAS 24-hour mean score
    Visual analogue scale from 0 to 100 mm. The statement put is: "Overall, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking". The mean value is calculated.
    Take Drug Again VAS Emax
    Visual analogue scale from 0 to 100 mm. The statement put is: "I would take this drug again" with anchor points "0: Definitely not" and "100: Definitely so". The maximum value recorded is chosen.
    Take Drug Again VAS 10-hour mean score
    Visual analogue scale from 0 to 100 mm. The statement put is: "I would take this drug again" with anchor points "0: Definitely not" and "100: Definitely so". The mean value is calculated
    Take Drug Again VAS 24-hour mean score
    Visual analogue scale from 0 to 100 mm. The statement put is: "I would take this drug again" with anchor points "0: Definitely not" and "100: Definitely so". The mean value is calculated
    Subjective Drug Value Emax
    The SDV is a proxy measure of reinforcing efficacy that involves a series of independent, theoretical forced choices between the drug administered and different monetary values.
    Subjective Drug Value 10 hour mean score
    The SDV is a proxy measure of reinforcing efficacy that involves a series of independent, theoretical forced choices between the drug administered and different monetary values
    Subjective Drug 24 hour mean scores
    The SDV is a proxy measure of reinforcing efficacy that involves a series of independent, theoretical forced choices between the drug administered and different monetary values
    High VAS Emax
    Visual analogue scale from 0 to 100 mm. The statement put is: "I am feeling high" with anchor points "0: Definitely not" and "100: Definitely so". The maximum value recorded is chosen.
    High VAS TWmean
    Visual analogue scale from 0 to 100 mm. The statement put is: "I am feeling high" with anchor points "0: Definitely not" and "100: Definitely so". Time weighted average score is calculated
    Good Effects VAS Emax
    Visual analogue scale from 0 to 100 mm. The statement put is: "I can feel good drug effects" with anchor points "0: Definitely not" and "100: Definitely so". The maximum value recorded is chosen
    Good Effects VAS TWmean
    Visual analogue scale from 0 to 100 mm. The statement put is: "I can feel good drug effects" with anchor points "0: Definitely not" and "100: Definitely so". Time weighted average score is calculated
    Addiction Research Center Inventory (ARCI) euphoria scale (MBG) Emax
    Questionnaire to assess possible addiction. The maximum value recorded is chosen
    Addiction Research Center Inventory (ARCI) euphoria scale (MBG) TWmean
    Questionnaire to assess possible addiction. The time-weighted mean value is calculated
    Bad Effects VAS Emax
    Visual analogue scale from 0 to 100 mm. The statement put is: "I can feel bad drug effects" with anchor points "0: 0: Definitely not" and "100: 0: Definitely so". The maximum value recorded is chosen
    Bad Effects VAS TWmean
    Visual analogue scale from 0 to 100 mm. The statement put is: "I can feel bad drug effects" with anchor points "0: Definitely not" and "100: Definitely so". Time weighted average score is calculated.
    ARCI dysphoria scale (LSD) Emax
    Questionnaire to assess possible addiction. The maximum value recorded is chosen
    ARCI dysphoria scale (LSD) TWmean
    Questionnaire to assess possible addiction. The time-weighted mean value is calculated
    ARCI sedation scale (PCAG) Emax
    Questionnaire to assess possible addiction. The maximum value recorded is chosen
    ARCI sedation scale (PCAG) TWmean
    Questionnaire to assess possible addiction. The time-weighted mean value is calculated
    Alertness/Drowsiness VAS Emin (drowsiness)
    Visual analogue scale from 0 to 100 mm. The statement put is: "I am feeling" with anchor points "0: Very Drowsy" and "100: Very Alert". The minimum value recorded is chosen
    Alertness/Drowsiness VAS TWmean
    Visual analogue scale from 0 to 100 mm. The statement put is: "I am feeling" with anchor points "0: Very Drowsy" and "100: Very Alert". The time weighted mean value is calculated
    Any Effects VAS Emax
    Visual analogue scale from 0 to 100 mm. The statement put is: "I can feel any drug effects" with anchor points "0: 0: Definitely not" and "100: 0: Definitely so". The maximum value recorded is chosen
    Any Effects VAS TWmean
    Visual analogue scale from 0 to 100 mm. The statement put is: "I can feel any drug effects" with anchor points "0: 0: Definitely not" and "100: 0: Definitely so". The time-weighted mean value is calculated
    Bowdle VAS Emax
    13 items for which the volunteer is asked to rate his/her feelings over the past 30 minutes. Each VAS will be scored from 0 to 100, with 0 reflecting "Not at all" and 100 reflecting "Extremely". The maximum value recorded is chosen
    Bowdle VAS TWmean
    13 items for which the volunteer is asked to rate his/her feelings over the past 30 minutes. Each VAS will be scored from 0 to 100, with 0 reflecting "Not at all" and 100 reflecting "Extremely". The time-weighted mean value is calculated
    ARCI A scale Emax
    Questionnaire to assess possible addiction. The maximum value recorded is chosen
    ARCI A scale TWmean
    Questionnaire to assess possible addiction. The time-weighted mean value is calculated
    ARCI Phentermine and Benzedrine Group scale (BG) Emax
    Questionnaire to assess possible addiction. The maximum value recorded is chosen
    ARCI Phentermine and Benzedrine Group scale (BG) TWmean
    Questionnaire to assess possible addiction. The time-weighted mean value is calculated

    Full Information

    First Posted
    December 6, 2011
    Last Updated
    March 21, 2012
    Sponsor
    AstraZeneca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01500018
    Brief Title
    Study in Healthy Recreational Polydrug Users to Measure the Abuse Potential of TC-5214
    Acronym
    TC-5214
    Official Title
    A Single-center, Single-dose, Double-blind, Randomized, Placebo- and Active-controlled Crossover Study to Evaluate the Abuse Potential of TC-5214 in Healthy Recreational Polydrug Users
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Sponsor decision to withdraw.
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    April 2012 (Anticipated)
    Study Completion Date
    April 2012 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    AstraZeneca

    4. Oversight

    5. Study Description

    Brief Summary
    This is a single dose, crossover study to assess the abuse potential of TC-5214 compared to placebo, ketamine, and phentermine in healthy recreational polydrug users.
    Detailed Description
    A Single-center, Single-dose, Double-blind, Randomized, Placebo- and Active-controlled Crossover Study to Evaluate the Abuse Potential of TC-5214 in Healthy Recreational Polydrug Users.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Drug Abuse, Healthy
    Keywords
    Phase I, healthy recreational polydrug users, abuse liability, TC-5214, Single dose crossover study to evaluate the abuse potential of TC-5214

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Crossover Treatment Sequence 1
    Arm Type
    Experimental
    Arm Description
    Period 1: Placebo, Period 2: Phentermine 45 mg, Period 3: Phentermine 90 mg, Period 4: Ketamine 100 mg, Period 5: TC-5214 2 mg, Period 6: TC-5214 8 mg, Period 7: TC-5214 16 mg
    Arm Title
    Crossover Treatment Sequence 2
    Arm Type
    Experimental
    Arm Description
    Period 1: Phentermine 45 mg, Period 2: Ketamine 100 mg , Period 3: Placebo, Period 4: TC-5214 8 mg , Period 5: Phentermine 90 mg, Period 6: TC-5214 16 mg, Period 7: TC-5214 2 mg
    Arm Title
    Crossover Treatment Sequence 3
    Arm Type
    Experimental
    Arm Description
    Period 1: Ketamine 100 mg, Period 2: TC-5214 8 mg, Period 3: Phentermine 45 mg, Period 4: TC-5214 16 mg, Period 5: Placebo, Period 6: TC-5214 2 mg, Period 7: Phentermine 90 mg
    Arm Title
    Crossover Treatment Sequence 4
    Arm Type
    Experimental
    Arm Description
    Period 1: TC-5214 8 mg, Period 2: TC-5214 16 mg, Period 3: Ketamine 100 mg, Period 4: TC-5214 2 mg, Period 5: Phentermine 45 mg , Period 6: Phentermine 90 mg, Period 7: Placebo
    Arm Title
    Crossover Treatment Sequence 5
    Arm Type
    Experimental
    Arm Description
    Period 1: TC-5214 16 mg, Period 2: TC-5214 2 mg, Period 3: TC-5214 8 mg, Period 4: Phentermine 90 mg, Period 5: Ketamine 100 mg, Period 6: Placebo , Period 7: Phentermine 45 mg
    Arm Title
    Crossover Treatment Sequence 6
    Arm Type
    Experimental
    Arm Description
    Period 1: TC-5214 2 mg, Period 2: Phentermine 90 mg, Period 3: TC-5214 16 mg, Period 4: Placebo, Period 5: TC-5214 8 mg, Period 6:Phentermine 45 mg , Period 7: Ketamine 100 mg
    Arm Title
    Crossover Treatment Sequence 7
    Arm Type
    Experimental
    Arm Description
    Period 1: Phentermine 90 mg, Period 2: Placebo, Period 3: TC-5214 2 mg, Period 4: Phentermine 45 mg, Period 5: TC-5214 16 mg, Period 6: Ketamine 100 mg, Period 7: TC-5214 8 mg
    Arm Title
    Crossover Treatment Sequence 8
    Arm Type
    Experimental
    Arm Description
    Period 1: TC-5214 16 mg, Period 2: TC-5214 8 mg, Period 3: TC-5214 2 mg, Period 4: Ketamine 100 mg, Period 5: Phentermine 90 mg, Period 6: Phentermine 45 mg, Period 7: Placebo
    Arm Title
    Crossover Treatment Sequence 9
    Arm Type
    Experimental
    Arm Description
    Period 1: TC-5214 2 mg, Period 2: TC-5214 16 mg, Period 3: Phentermine 90 mg, Period 4: TC-5214 8 mg, Period 5: Placebo, Period 6: Ketamine 100 mg, Period 7: Phentermine 45 mg
    Arm Title
    Crossover Treatment Sequence 10
    Arm Type
    Experimental
    Arm Description
    Period 1: Phentermine 90 mg, Period 2: TC-5214 2 mg, Period 3: Placebo, Period 4: TC-5214 16 mg Ketamine 100 mg, Period 5: Phentermine 45 mg, Period 6: TC-5214 8 mg, Period 7: TC-5214 2 mg
    Arm Title
    Crossover Treatment Sequence 11
    Arm Type
    Experimental
    Arm Description
    Period 1: Placebo, Period 2: Phentermine 90 mg, Period 3:Phentermine 45 mg, Period 4: TC-5214 2 mg, Period 5: Ketamine 100 mg, Period 6: TC-5214 16 mg, Period 7: TC-5214 8 mg
    Arm Title
    Crossover Treatment Sequence 12
    Arm Type
    Experimental
    Arm Description
    Period 1: Phentermine 45 mg, Period 2: Placebo, Period 3: Ketamine 100 mg, Period 4:Phentermine 90 mg, Period 5: TC-5214 8 mg, Period 6: TC-5214 2 mg, Period 7: TC-5214 16 mg
    Arm Title
    Crossover Treatment Sequence 13
    Arm Type
    Experimental
    Arm Description
    Period 1: Ketamine 100 mg, Period 2: Phentermine 45 mg, Period 3: TC-5214 8 mg, Period 4: Placebo, Period 5: TC-5214 16 mg, Period 6: Phentermine 90 mg, Period 7: TC-5214 2 mg
    Arm Title
    Crossover Treatment Sequence 14
    Arm Type
    Experimental
    Arm Description
    Period 1: TC-5214 8 mg, Period 2: Ketamine 100 mg, Period 3: TC-5214 16 mg, Period 4: Phentermine 45 mg, Period 5: TC-5214 2 mg, Period 6: Placebo, Period 7: Phentermine 90 mg
    Intervention Type
    Drug
    Intervention Name(s)
    TC-5214
    Intervention Description
    Single oral dose of 2 mg
    Intervention Type
    Drug
    Intervention Name(s)
    TC-5214 Placebo
    Intervention Description
    Single oral dose
    Intervention Type
    Drug
    Intervention Name(s)
    Ketamine
    Intervention Description
    Single oral dose of 100 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Phentermine
    Intervention Description
    Single oral dose of 45 mg
    Intervention Type
    Drug
    Intervention Name(s)
    TC-5214
    Intervention Description
    Single oral dose of 8 mg
    Intervention Type
    Drug
    Intervention Name(s)
    TC-5214
    Intervention Description
    Single oral dose of 16 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Phentermine
    Intervention Description
    Single oral dose of 90 mg
    Primary Outcome Measure Information:
    Title
    Momentary Drug Liking VAS maximum effect (Emax)
    Description
    Visual analogue scale from 0 to 100 mm. The statement put is: "At this moment, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking". The maximum value recorded is chosen.
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Secondary Outcome Measure Information:
    Title
    Momentary Drug Liking VAS minimum effect (Emin)
    Description
    Visual analogue scale from 0 to 100 mm. The statement put is: "At this moment, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking" The minimum value recorded is chosen.
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    Drug Liking VAS time-weighted mean (TWmean)
    Description
    Visual analogue scale from 0 to 100 mm. The statement put is: "At this moment, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking". Time weighted average score is calculated.
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    Overall Drug Liking VAS maximum effect ( Emax)
    Description
    Visual analogue scale from 0 to 100 mm. The statement put is: "Overall, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking". The maximum value recorded is chosen.
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    Overall Drug Liking VAS (Emin)
    Description
    Visual analogue scale from 0 to 100 mm. The statement put is: "Overall, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking". The minimum value recorded is chosen
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    Overall Drug Liking VAS 10-hour mean score
    Description
    Visual analogue scale from 0 to 100 mm. The statement put is: "Overall, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking". The mean value is calculated.
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8 and 10 hours post dose
    Title
    Overall Drug Liking VAS 24-hour mean score
    Description
    Visual analogue scale from 0 to 100 mm. The statement put is: "Overall, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking". The mean value is calculated.
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    Take Drug Again VAS Emax
    Description
    Visual analogue scale from 0 to 100 mm. The statement put is: "I would take this drug again" with anchor points "0: Definitely not" and "100: Definitely so". The maximum value recorded is chosen.
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    Take Drug Again VAS 10-hour mean score
    Description
    Visual analogue scale from 0 to 100 mm. The statement put is: "I would take this drug again" with anchor points "0: Definitely not" and "100: Definitely so". The mean value is calculated
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8 and 10 hours post dose
    Title
    Take Drug Again VAS 24-hour mean score
    Description
    Visual analogue scale from 0 to 100 mm. The statement put is: "I would take this drug again" with anchor points "0: Definitely not" and "100: Definitely so". The mean value is calculated
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    Subjective Drug Value Emax
    Description
    The SDV is a proxy measure of reinforcing efficacy that involves a series of independent, theoretical forced choices between the drug administered and different monetary values.
    Time Frame
    10 and 24 hours post dose
    Title
    Subjective Drug Value 10 hour mean score
    Description
    The SDV is a proxy measure of reinforcing efficacy that involves a series of independent, theoretical forced choices between the drug administered and different monetary values
    Time Frame
    10 hours post dose
    Title
    Subjective Drug 24 hour mean scores
    Description
    The SDV is a proxy measure of reinforcing efficacy that involves a series of independent, theoretical forced choices between the drug administered and different monetary values
    Time Frame
    10 and 24 hours post dose
    Title
    High VAS Emax
    Description
    Visual analogue scale from 0 to 100 mm. The statement put is: "I am feeling high" with anchor points "0: Definitely not" and "100: Definitely so". The maximum value recorded is chosen.
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    High VAS TWmean
    Description
    Visual analogue scale from 0 to 100 mm. The statement put is: "I am feeling high" with anchor points "0: Definitely not" and "100: Definitely so". Time weighted average score is calculated
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    Good Effects VAS Emax
    Description
    Visual analogue scale from 0 to 100 mm. The statement put is: "I can feel good drug effects" with anchor points "0: Definitely not" and "100: Definitely so". The maximum value recorded is chosen
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    Good Effects VAS TWmean
    Description
    Visual analogue scale from 0 to 100 mm. The statement put is: "I can feel good drug effects" with anchor points "0: Definitely not" and "100: Definitely so". Time weighted average score is calculated
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    Addiction Research Center Inventory (ARCI) euphoria scale (MBG) Emax
    Description
    Questionnaire to assess possible addiction. The maximum value recorded is chosen
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    Addiction Research Center Inventory (ARCI) euphoria scale (MBG) TWmean
    Description
    Questionnaire to assess possible addiction. The time-weighted mean value is calculated
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    Bad Effects VAS Emax
    Description
    Visual analogue scale from 0 to 100 mm. The statement put is: "I can feel bad drug effects" with anchor points "0: 0: Definitely not" and "100: 0: Definitely so". The maximum value recorded is chosen
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    Bad Effects VAS TWmean
    Description
    Visual analogue scale from 0 to 100 mm. The statement put is: "I can feel bad drug effects" with anchor points "0: Definitely not" and "100: Definitely so". Time weighted average score is calculated.
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    ARCI dysphoria scale (LSD) Emax
    Description
    Questionnaire to assess possible addiction. The maximum value recorded is chosen
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    ARCI dysphoria scale (LSD) TWmean
    Description
    Questionnaire to assess possible addiction. The time-weighted mean value is calculated
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    ARCI sedation scale (PCAG) Emax
    Description
    Questionnaire to assess possible addiction. The maximum value recorded is chosen
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    ARCI sedation scale (PCAG) TWmean
    Description
    Questionnaire to assess possible addiction. The time-weighted mean value is calculated
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    Alertness/Drowsiness VAS Emin (drowsiness)
    Description
    Visual analogue scale from 0 to 100 mm. The statement put is: "I am feeling" with anchor points "0: Very Drowsy" and "100: Very Alert". The minimum value recorded is chosen
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    Alertness/Drowsiness VAS TWmean
    Description
    Visual analogue scale from 0 to 100 mm. The statement put is: "I am feeling" with anchor points "0: Very Drowsy" and "100: Very Alert". The time weighted mean value is calculated
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    Any Effects VAS Emax
    Description
    Visual analogue scale from 0 to 100 mm. The statement put is: "I can feel any drug effects" with anchor points "0: 0: Definitely not" and "100: 0: Definitely so". The maximum value recorded is chosen
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    Any Effects VAS TWmean
    Description
    Visual analogue scale from 0 to 100 mm. The statement put is: "I can feel any drug effects" with anchor points "0: 0: Definitely not" and "100: 0: Definitely so". The time-weighted mean value is calculated
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    Bowdle VAS Emax
    Description
    13 items for which the volunteer is asked to rate his/her feelings over the past 30 minutes. Each VAS will be scored from 0 to 100, with 0 reflecting "Not at all" and 100 reflecting "Extremely". The maximum value recorded is chosen
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    Bowdle VAS TWmean
    Description
    13 items for which the volunteer is asked to rate his/her feelings over the past 30 minutes. Each VAS will be scored from 0 to 100, with 0 reflecting "Not at all" and 100 reflecting "Extremely". The time-weighted mean value is calculated
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    ARCI A scale Emax
    Description
    Questionnaire to assess possible addiction. The maximum value recorded is chosen
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    ARCI A scale TWmean
    Description
    Questionnaire to assess possible addiction. The time-weighted mean value is calculated
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    ARCI Phentermine and Benzedrine Group scale (BG) Emax
    Description
    Questionnaire to assess possible addiction. The maximum value recorded is chosen
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
    Title
    ARCI Phentermine and Benzedrine Group scale (BG) TWmean
    Description
    Questionnaire to assess possible addiction. The time-weighted mean value is calculated
    Time Frame
    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Current recreational polydrug users with experience with at least 2 drug classes of abuse. At least 10 lifetime uses of stimulants drugs (eg, amphetamine, cocaine, methamphetamine) and 10 lifetime occasions of recreational use of psychedelic drugs (eg, cannabis, ketamine, dextromethorphan, PCP, MDMA [ecstasy], LSD, mesacline, or psilocybin). Recreational use of other classes of drugs is permitted, including opioids (eg, codeine, morphine, or heroin), minor tranquilizers, or sedatives (eg, benzodiazepines or barbiturates). Male or female volunteers aged 18 to 55, inclusive with a body mass index (BMI) within the range of 19.0 to 33.0 kg/m2, inclusive, and a minimum weight of 50.0 kg at screening. Must pass qualification phase eligibility criteria. Exclusion Criteria: Self-reported history of drug or alcohol dependence (except caffeine) in the past 12 months, including subjects who have ever been in a drug rehabilitation program (other than treatment for smoking cessation). Unwillingness or inability to abstain from recreational drug use for the duration of the study from screening until follow-up. Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at screening. Any significant unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or any other medical conditions that might confound the study or put the volunteer at greater risk during study participation. Currently smoking more than 20 cigarettes (or 2 cigars) per day, and/or unwillingness to abstain from smoking for durations of at least 12 hours. Use of tobacco cessation product within 1 month (eg, nicotine substitution products, bupropion, etc).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hans A Eriksson, MD
    Organizational Affiliation
    AstraZeneca Kvzmbergagatan 12, 15185,Sodertalje, Sweden
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Pierre Geoffroy, MDCM, MSC, FCFP
    Organizational Affiliation
    Syneos Health
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Brendan Smyth, MD
    Organizational Affiliation
    AstraZeneca 180 Concord Pike, Wilmington,DE 19850-5437
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study in Healthy Recreational Polydrug Users to Measure the Abuse Potential of TC-5214

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