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Effects of Low-dose Naltrexone in Combination With a Range of Smoked Marijuana

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ClinicalTrials.gov Identifier: NCT00743145
Recruitment Status : Completed
First Posted : August 28, 2008
Results First Posted : September 14, 2018
Last Update Posted : September 14, 2018
Sponsor:
Collaborators:
Research Foundation for Mental Hygiene, Inc.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Margaret Haney, New York State Psychiatric Institute

Study Description
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Brief Summary:
In heavy marijuana smokers, opioid receptor blockade increases the subjective and cardiovascular effects of marijuana. The current study was designed to clarify opioid-cannabinoid interactions by assessing how naltrexone shifts the dose-response function for marijuana-elicited effects in heavy marijuana smokers. For this within-subject, double-blind study, a marijuana smoking procedure was designed to characterize a dose-response relationship for marijuana's subjective and cardiovascular effects under blinded conditions.

Condition or disease Intervention/treatment Phase
Marijuana Smoking Drug: Inactive Marijuana (0% THC) Drug: Active Marijuana (5.5% THC) Drug: Active Marijuana (6.2% THC) Drug: Naltrexone Drug: Placebo naltrexone Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double-blind, placebo-controlled
Primary Purpose: Basic Science
Official Title: Effects of Low-dose Naltrexone in Combination With a Range of Smoked Marijuana
Study Start Date : May 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo naltrexone + Inactive marijuana
Placebo naltrexone capsules (0mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order.
 Drug: Inactive Marijuana (0% THC)
Marijuana cigarette containing 0% THC
Other Name: Cannabis

Drug: Placebo naltrexone
Naltrexone (0mg)
Other Name: PBO
Placebo Comparator: Placebo naltrexone + Active marijuana (5.5% THC)
Placebo naltrexone capsules (0mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order.
 Drug: Active Marijuana (5.5% THC)
Marijuana cigarette containing 5.5% THC
Other Name: Cannabis

Drug: Placebo naltrexone
Naltrexone (0mg)
Other Name: PBO
Placebo Comparator: Placebo naltrexone + Active marijuana (6.2% THC)
Placebo naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order.
 Drug: Active Marijuana (6.2% THC)
Marijuana cigarette containing 6.2% THC
Other Name: Cannabis

Drug: Placebo naltrexone
Naltrexone (0mg)
Other Name: PBO
Experimental: Naltrexone + Active marijuana (5.5% THC)
Naltrexone capsules (12mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order.
 Drug: Active Marijuana (5.5% THC)
Marijuana cigarette containing 5.5% THC
Other Name: Cannabis

Drug: Naltrexone
Naltrexone (12mg/70kg)
Other Name: Revia
Experimental: Naltrexone + Active marijuana (6.2% THC)
Naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order.
 Drug: Active Marijuana (6.2% THC)
Marijuana cigarette containing 6.2% THC
Other Name: Cannabis

Drug: Naltrexone
Naltrexone (12mg/70kg)
Other Name: Revia
Placebo Comparator: Naltrexone + Inactive marijuana
Naltrexone capsules (12mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order.
 Drug: Inactive Marijuana (0% THC)
Marijuana cigarette containing 0% THC
Other Name: Cannabis

Drug: Naltrexone
Naltrexone (12mg/70kg)
Other Name: Revia


Outcome Measures
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Primary Outcome Measures :
  1. Subjective Marijuana Effects [ Time Frame: 180 minutes after marijuana administration, during each of 8 outpatient sessions over the course of 3-6 weeks. ]
    Subjective ratings of marijuana's quality and effect ('Strength', 'Good Effect', 'High', 'Stimulation') and craving ('Want Marijuana') as a function of active puffs and naltrexone, using a visual analogue scale with 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 indicate how they felt at that particular moment. Higher ratings indicate more agreement with the statement.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Current marijuana use
  • Able to perform study procedures
  • 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, hepatitis, clinically significant laboratory abnormalities, LFTs > 3x upper limit of normal, blood pressure > 140/90
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00743145


Locations
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United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Research Foundation for Mental Hygiene, Inc.
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Margaret Haney, Ph.D. New York State Psychiatric Institute
More Information
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Responsible Party: Margaret Haney, Clinical Psychaitrist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00743145    
Other Study ID Numbers: IRB# 5693
DA19239 ( Other Grant/Funding Number: National Institute on Drug Abuse (NIDA) )
First Posted: August 28, 2008    Key Record Dates
Results First Posted: September 14, 2018
Last Update Posted: September 14, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Margaret Haney, New York State Psychiatric Institute:
naltrexone
smoked marijuana
marijuana use
Additional relevant MeSH terms:
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Marijuana Abuse
Marijuana Use
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
 Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents