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Reducing Drug Craving Memories

Primary Purpose

Cocaine Addiction

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inderal
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Addiction focused on measuring cocaine addiction treatment craving

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 60 psychotropic medication-free men or women (15 subjects x 4 groups) who have met DSM-IV-TR diagnostic criteria for cocaine dependence for the past 6 months (age 18 - 50 years old);
  • Minimum of three days cocaine abstinent on study days;
  • Primary use of cocaine is intra-nasal or smoked crack

Exclusion Criteria:

  • Medical conditions that might be aggravated by participation in the study:

    • cardiovascular disorders that might be aggravated by participation in the study: hypotension (SBP: < 100 mmHg), bradycardia (heart rate < 60 /min), severe atrioventricular block (Type II or III), severe hypertension (SBP: > 160 mmHg; DBP: > 100 mmHg), myocardial infarction, history of chest pain and admission to ED for chest pain;
    • respiratory disorders: bronchial asthma and chronic obstructive pulmonary disease;
    • diabetic patients treated with insulin or oral hypoglycemic agents. Propranolol may mask the first signs of a developing hypoglycemia.
  • Seropositive pregnancy test
  • Comorbidity with current axis I psychiatric disorders other than anxiety, affective and substance use disorders
  • Severe liver disfunction
  • Current or recent (< 5 half lives) use of medications that may interact with Inderal (see above)
  • Positive urine tox screen for barbiturates. Positive breath alcohol screen. {Note: all urine tox screen results will be destroyed immediately after collection. The information will not be stored}

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Inderal, neutral cues

    Inderal, drug cues

    Placebo, neutral cues

    Placebo, drug cues

    Arm Description

    Outcomes

    Primary Outcome Measures

    Self-report drug craving
    One day and one month after the intervention, the investigators will measure drug craving using visual analog scales (VAS) and the Cocaine Craving Questionnaire (CCQ).

    Secondary Outcome Measures

    Drug use
    One month after the intervention, participants will be interviewed about their drug and alcohol use

    Full Information

    First Posted
    March 18, 2011
    Last Updated
    May 18, 2011
    Sponsor
    McGill University Health Centre/Research Institute of the McGill University Health Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01319214
    Brief Title
    Reducing Drug Craving Memories
    Official Title
    Reconsolidation as a Treatment Target for Cocaine Addiction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2011 (undefined)
    Primary Completion Date
    March 2015 (Anticipated)
    Study Completion Date
    March 2015 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    McGill University Health Centre/Research Institute of the McGill University Health Centre

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The primary objective is to investigate the potential ability of Inderal (propranolol hydrochloride) to diminish the reconsolidation of motivationally potent drug-related cues in cocaine dependent participants. If effective in this laboratory model, Inderal may have clinical efficacy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cocaine Addiction
    Keywords
    cocaine addiction treatment craving

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Inderal, neutral cues
    Arm Type
    Experimental
    Arm Title
    Inderal, drug cues
    Arm Type
    Experimental
    Arm Title
    Placebo, neutral cues
    Arm Type
    Experimental
    Arm Title
    Placebo, drug cues
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Inderal
    Intervention Description
    Inderal vs. placebo will be administered with or without cocaine cues
    Primary Outcome Measure Information:
    Title
    Self-report drug craving
    Description
    One day and one month after the intervention, the investigators will measure drug craving using visual analog scales (VAS) and the Cocaine Craving Questionnaire (CCQ).
    Time Frame
    One day and one month post-treatment
    Secondary Outcome Measure Information:
    Title
    Drug use
    Description
    One month after the intervention, participants will be interviewed about their drug and alcohol use
    Time Frame
    One month after the intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 60 psychotropic medication-free men or women (15 subjects x 4 groups) who have met DSM-IV-TR diagnostic criteria for cocaine dependence for the past 6 months (age 18 - 50 years old); Minimum of three days cocaine abstinent on study days; Primary use of cocaine is intra-nasal or smoked crack Exclusion Criteria: Medical conditions that might be aggravated by participation in the study: cardiovascular disorders that might be aggravated by participation in the study: hypotension (SBP: < 100 mmHg), bradycardia (heart rate < 60 /min), severe atrioventricular block (Type II or III), severe hypertension (SBP: > 160 mmHg; DBP: > 100 mmHg), myocardial infarction, history of chest pain and admission to ED for chest pain; respiratory disorders: bronchial asthma and chronic obstructive pulmonary disease; diabetic patients treated with insulin or oral hypoglycemic agents. Propranolol may mask the first signs of a developing hypoglycemia. Seropositive pregnancy test Comorbidity with current axis I psychiatric disorders other than anxiety, affective and substance use disorders Severe liver disfunction Current or recent (< 5 half lives) use of medications that may interact with Inderal (see above) Positive urine tox screen for barbiturates. Positive breath alcohol screen. {Note: all urine tox screen results will be destroyed immediately after collection. The information will not be stored}

    12. IPD Sharing Statement

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    Reducing Drug Craving Memories

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