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Effects of a Range of Naltrexone Doses in Combination With Smoked Marijuana

Primary Purpose

Marijuana Use

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Placebo + Inactive Marijuana (0% THC)
Placebo + Active Marijuana (3.27% THC)
Naltrexone 12 Mg+ Active Marijuana (3.27% THC)
Naltrexone 25 Mg + Active Marijuana (3.27% THC)
Naltrexone 50 Mg+ Active Marijuana (3.27% THC)
Naltrexone 100 Mg+ Active Marijuana (3.27% THC)
Naltrexone 12 Mg + Inactive Marijuana (0% THC)
Naltrexone 25 Mg + Inactive Marijuana (0% THC)
Naltrexone 50 Mg + Inactive Marijuana (0% THC)
Naltrexone 100 Mg + Inactive Marijuana (0% THC)
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Marijuana Use focused on measuring Naltrexone, Smoked Marijuana

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Current marijuana use
  • Able to perform study procedures
  • 21-45 years of age
  • Women practicing an effective form of birth control

Exclusion Criteria:

  • Current, repeated illicit drug use (other than marijuana)
  • Presence of significant medical illness (e.g., diabetes, cardiovascular disease, hypertension, examination, laboratory hepatitis, clinically significant laboratory abnormalities, tests, 12-lead ECG, Mantoux test LFTs > 3x upper limit of normal)
  • History of heart disease
  • Request for drug treatment
  • Current parole or probation
  • Pregnancy or current lactation
  • Recent history of significant violent behavior
  • Previous adverse reaction to naltrexone
  • Major current Axis I psychopathology Psychiatric interview (e.g., major depressive disorder, bipolar disorder, suicide risk, schizophrenia)
  • Current use of any prescription or over-the-counter medication

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 Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Placebo, Marijuana (0% THC)

    Placebo, Marijuana (3.27% THC)

    Naltrexone (12mg), Marijuana (0% THC)

    Naltrexone (12mg), Marijuana (3.27% THC)

    Naltrexone (25mg), Marijuana (0% THC)

    Naltrexone (25mg), Marijuana (3.27% THC)

    Naltrexone (50mg), Marijuana (0% THC)

    Naltrexone (50mg), Marijuana (3.27% THC)

    Naltrexone (100mg), Marijuana (0% THC)

    Naltrexone (100mg), Marijuana (3.27% THC)

    Arm Description

    During each session, one capsule containing placebo was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (0% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration.

    During each session, one capsule containing placebo was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration.

    During each session, one capsule containing naltrexone (12 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (0% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration.

    During each session, one capsule containing naltrexone (12 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration.

    During each session, one capsule containing naltrexone (25 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (0% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration.

    During each session, one capsule containing naltrexone (25 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration.

    During each session, one capsule containing naltrexone (50 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (0% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration.

    During each session, one capsule containing naltrexone (50 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration.

    During each session, one capsule containing naltrexone (100 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (0% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration.

    During each session, one capsule containing naltrexone (100 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration.

    Outcomes

    Primary Outcome Measures

    Change in Mean Subjective Mood Scores as a Function of Marijuana Strength and Naltrexone Dose.
    All subjective effects were measured using visual analog scales (VAS), a series of 100 mm long lines labeled 'not at all' at one end (0 mm) and 'extremely' at the other end (100 mm). Participants were instructed to rate their subjective experiences on the line according to how they felt at that particular moment. Subjective assessments included measures of perceived marijuana strength, marijuana "high", "good effects" of marijuana, and how much marijuana was "liked". Marijuana's effects were determined by comparing the active and inactive marijuana conditions when paired with the placebo naltrexone condition (one comparison). Naltrexone's intrinsic effects were assessed by comparing placebo and each active dose of naltrexone (12, 25, 50, and 100 mg) under the inactive marijuana condition (four comparisons). Finally, the active marijuana- placebo naltrexone condition was compared to the active marijuana-active naltrexone conditions (four comparisons)
    Change in Mean Psychomotor Task Performance as a Function of Marijuana Strength and Naltrexone Dose
    Change in Digit Symbol Substitution Test (DSST) scores. Increasing scores indicate improvement, on a scale of 0-90. The task batteries included total correct attempts on a 3-min DSST.
    Change in Mean Heart Rate as a Function of Marijuana Strength and Naltrexone Dose.
    Change in mean heart rate as a function of marijuana and naltrexone dose

    Secondary Outcome Measures

    Full Information

    First Posted
    November 21, 2006
    Last Updated
    February 15, 2018
    Sponsor
    New York State Psychiatric Institute
    Collaborators
    Research Foundation for Mental Hygiene, Inc., National Institute on Drug Abuse (NIDA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00403117
    Brief Title
    Effects of a Range of Naltrexone Doses in Combination With Smoked Marijuana
    Official Title
    Opioid Antagonism Enhances Marijuana's Effects in Heavy Marijuana Smokers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2006 (undefined)
    Primary Completion Date
    May 2008 (Actual)
    Study Completion Date
    August 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    New York State Psychiatric Institute
    Collaborators
    Research Foundation for Mental Hygiene, Inc., National Institute on Drug Abuse (NIDA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine if the subjective effects of marijuana will be decreased by low-doses (< 25 mg) of naltrexone and increased by high-doses (> 50 mg) of naltrexone.
    Detailed Description
    Laboratory animal studies demonstrate that endogenous cannabinoids and opioids are closely inter-related. We have completed a series of studies in marijuana smokers showing that a clinically-utilized dose of naltrexone (50 mg) enhanced the reinforcing and subjective effects of orally-administered tetrahydrocannabinol (THC), while a low naltrexone dose (12 mg) blunted the effects of THC. A better understanding of the effects of a range of naltrexone doses in combination with smoked marijuana has important implications for the following reasons: (1) Alcohol- and opioid-dependent patients receive high doses of naltrexone (50-150 mg), which may increase the abuse liability of marijuana, (2) Low-dose naltrexone blunts THC's intoxicating effects, suggesting potential utility as a treatment medication for marijuana dependence. This study will determine if naltrexone (0, 12, 25, 50, 100 mg) administration 45 min prior to marijuana administration (0, 3.27% THC) alters marijuana's subjective, cognitive or physiological effects. Marijuana smokers will spend approximately 5h/day for a total of 10 days in the outpatient laboratory. Participants will visit the outpatient laboratory 2-3 times per week, with a minimum 48-hr interval between sessions to allow for naltrexone clearance. These data will provide important information regarding the clinical use of naltrexone.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Marijuana Use
    Keywords
    Naltrexone, Smoked Marijuana

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigator
    Masking Description
    double-blind, placebo-controlled
    Allocation
    Randomized
    Enrollment
    49 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo, Marijuana (0% THC)
    Arm Type
    Placebo Comparator
    Arm Description
    During each session, one capsule containing placebo was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (0% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration.
    Arm Title
    Placebo, Marijuana (3.27% THC)
    Arm Type
    Experimental
    Arm Description
    During each session, one capsule containing placebo was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration.
    Arm Title
    Naltrexone (12mg), Marijuana (0% THC)
    Arm Type
    Experimental
    Arm Description
    During each session, one capsule containing naltrexone (12 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (0% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration.
    Arm Title
    Naltrexone (12mg), Marijuana (3.27% THC)
    Arm Type
    Experimental
    Arm Description
    During each session, one capsule containing naltrexone (12 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration.
    Arm Title
    Naltrexone (25mg), Marijuana (0% THC)
    Arm Type
    Experimental
    Arm Description
    During each session, one capsule containing naltrexone (25 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (0% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration.
    Arm Title
    Naltrexone (25mg), Marijuana (3.27% THC)
    Arm Type
    Experimental
    Arm Description
    During each session, one capsule containing naltrexone (25 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration.
    Arm Title
    Naltrexone (50mg), Marijuana (0% THC)
    Arm Type
    Experimental
    Arm Description
    During each session, one capsule containing naltrexone (50 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (0% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration.
    Arm Title
    Naltrexone (50mg), Marijuana (3.27% THC)
    Arm Type
    Experimental
    Arm Description
    During each session, one capsule containing naltrexone (50 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration.
    Arm Title
    Naltrexone (100mg), Marijuana (0% THC)
    Arm Type
    Experimental
    Arm Description
    During each session, one capsule containing naltrexone (100 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (0% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration.
    Arm Title
    Naltrexone (100mg), Marijuana (3.27% THC)
    Arm Type
    Experimental
    Arm Description
    During each session, one capsule containing naltrexone (100 mg) was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo + Inactive Marijuana (0% THC)
    Other Intervention Name(s)
    treatment type 1
    Intervention Description
    One capsule containing placebo was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo + Active Marijuana (3.27% THC)
    Other Intervention Name(s)
    treatment type 2
    Intervention Description
    One capsule containing placebo was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before administration of a marijuana cigarette containing 3.27% THC (ca. 800 mg) provided by the National Institute on Drug Abuse.
    Intervention Type
    Drug
    Intervention Name(s)
    Naltrexone 12 Mg+ Active Marijuana (3.27% THC)
    Other Intervention Name(s)
    Treatment type 3
    Intervention Description
    One capsule containing 12mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before active marijuana administration.
    Intervention Type
    Drug
    Intervention Name(s)
    Naltrexone 25 Mg + Active Marijuana (3.27% THC)
    Other Intervention Name(s)
    treatment type 4
    Intervention Description
    One capsule containing 12mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before active marijuana administration.
    Intervention Type
    Drug
    Intervention Name(s)
    Naltrexone 50 Mg+ Active Marijuana (3.27% THC)
    Other Intervention Name(s)
    treatment type 5
    Intervention Description
    One capsule containing 25mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration.
    Intervention Type
    Drug
    Intervention Name(s)
    Naltrexone 100 Mg+ Active Marijuana (3.27% THC)
    Other Intervention Name(s)
    treatment type 6
    Intervention Description
    One capsule containing 50mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration.
    Intervention Type
    Drug
    Intervention Name(s)
    Naltrexone 12 Mg + Inactive Marijuana (0% THC)
    Other Intervention Name(s)
    treatment type 7
    Intervention Description
    One capsule containing 12mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before inactive marijuana administration.
    Intervention Type
    Drug
    Intervention Name(s)
    Naltrexone 25 Mg + Inactive Marijuana (0% THC)
    Other Intervention Name(s)
    treatment type 8
    Intervention Description
    One capsule containing 25mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before inactive marijuana administration.
    Intervention Type
    Drug
    Intervention Name(s)
    Naltrexone 50 Mg + Inactive Marijuana (0% THC)
    Other Intervention Name(s)
    treatment type 9
    Intervention Description
    One capsule containing 50mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before inactive marijuana administration.
    Intervention Type
    Drug
    Intervention Name(s)
    Naltrexone 100 Mg + Inactive Marijuana (0% THC)
    Other Intervention Name(s)
    treatment type 10
    Intervention Description
    One capsule containing 100mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before inactive marijuana administration.
    Primary Outcome Measure Information:
    Title
    Change in Mean Subjective Mood Scores as a Function of Marijuana Strength and Naltrexone Dose.
    Description
    All subjective effects were measured using visual analog scales (VAS), a series of 100 mm long lines labeled 'not at all' at one end (0 mm) and 'extremely' at the other end (100 mm). Participants were instructed to rate their subjective experiences on the line according to how they felt at that particular moment. Subjective assessments included measures of perceived marijuana strength, marijuana "high", "good effects" of marijuana, and how much marijuana was "liked". Marijuana's effects were determined by comparing the active and inactive marijuana conditions when paired with the placebo naltrexone condition (one comparison). Naltrexone's intrinsic effects were assessed by comparing placebo and each active dose of naltrexone (12, 25, 50, and 100 mg) under the inactive marijuana condition (four comparisons). Finally, the active marijuana- placebo naltrexone condition was compared to the active marijuana-active naltrexone conditions (four comparisons)
    Time Frame
    Baseline compared to 6 week timepoint
    Title
    Change in Mean Psychomotor Task Performance as a Function of Marijuana Strength and Naltrexone Dose
    Description
    Change in Digit Symbol Substitution Test (DSST) scores. Increasing scores indicate improvement, on a scale of 0-90. The task batteries included total correct attempts on a 3-min DSST.
    Time Frame
    Baseline compared to 6 week timepoint
    Title
    Change in Mean Heart Rate as a Function of Marijuana Strength and Naltrexone Dose.
    Description
    Change in mean heart rate as a function of marijuana and naltrexone dose
    Time Frame
    Baseline compared to 6 week timepoint

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Current marijuana use Able to perform study procedures 21-45 years of age Women practicing an effective form of birth control Exclusion Criteria: Current, repeated illicit drug use (other than marijuana) Presence of significant medical illness (e.g., diabetes, cardiovascular disease, hypertension, examination, laboratory hepatitis, clinically significant laboratory abnormalities, tests, 12-lead ECG, Mantoux test LFTs > 3x upper limit of normal) History of heart disease Request for drug treatment Current parole or probation Pregnancy or current lactation Recent history of significant violent behavior Previous adverse reaction to naltrexone Major current Axis I psychopathology Psychiatric interview (e.g., major depressive disorder, bipolar disorder, suicide risk, schizophrenia) Current use of any prescription or over-the-counter medication
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Margaret Haney, Ph.D.
    Organizational Affiliation
    New York State Psychiatric Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effects of a Range of Naltrexone Doses in Combination With Smoked Marijuana

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