- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00403117
Effects of a Range of Naltrexone Doses in Combination With Smoked Marijuana
Opioid Antagonism Enhances Marijuana's Effects in Heavy Marijuana Smokers
Study Overview
Status
Conditions
Intervention / Treatment
- Drug: Placebo + Inactive Marijuana (0% THC)
- Drug: Placebo + Active Marijuana (3.27% THC)
- Drug: Naltrexone 12 Mg + Inactive Marijuana (0% THC)
- Drug: Naltrexone 12 Mg+ Active Marijuana (3.27% THC)
- Drug: Naltrexone 25 Mg + Inactive Marijuana (0% THC)
- Drug: Naltrexone 25 Mg + Active Marijuana (3.27% THC)
- Drug: Naltrexone 50 Mg + Inactive Marijuana (0% THC)
- Drug: Naltrexone 50 Mg+ Active Marijuana (3.27% THC)
- Drug: Naltrexone 100 Mg + Inactive Marijuana (0% THC)
- Drug: Naltrexone 100 Mg+ Active Marijuana (3.27% THC)
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo, Marijuana (0% THC)
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.
|
One capsule containing placebo was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration.
Other Names:
|
Experimental: Placebo, Marijuana (3.27% THC)
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.
|
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.
Other Names:
|
Experimental: Naltrexone (12mg), Marijuana (0% THC)
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.
|
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.
Other Names:
|
Experimental: Naltrexone (12mg), Marijuana (3.27% THC)
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.
|
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.
Other Names:
|
Experimental: Naltrexone (25mg), Marijuana (0% THC)
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.
|
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.
Other Names:
|
Experimental: Naltrexone (25mg), Marijuana (3.27% THC)
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.
|
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.
Other Names:
|
Experimental: Naltrexone (50mg), Marijuana (0% THC)
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.
|
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.
Other Names:
|
Experimental: Naltrexone (50mg), Marijuana (3.27% THC)
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.
|
One capsule containing 25mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration.
Other Names:
|
Experimental: Naltrexone (100mg), Marijuana (0% THC)
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.
|
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.
Other Names:
|
Experimental: Naltrexone (100mg), Marijuana (3.27% THC)
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.
|
One capsule containing 50mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Mean Subjective Mood Scores as a Function of Marijuana Strength and Naltrexone Dose.
Time Frame: Baseline compared to 6 week timepoint
|
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) |
Baseline compared to 6 week timepoint
|
Change in Mean Psychomotor Task Performance as a Function of Marijuana Strength and Naltrexone Dose
Time Frame: Baseline compared to 6 week timepoint
|
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. |
Baseline compared to 6 week timepoint
|
Change in Mean Heart Rate as a Function of Marijuana Strength and Naltrexone Dose.
Time Frame: Baseline compared to 6 week timepoint
|
Change in mean heart rate as a function of marijuana and naltrexone dose
|
Baseline compared to 6 week timepoint
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB# 5350
- DA09236 (Other Grant/Funding Number: National Institute on Drug Abuse (NIDA))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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