Effects of Low-dose Naltrexone in Combination With a Range of Smoked Marijuana
2 other identifiers
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2008
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 26, 2008
CompletedFirst Posted
Study publicly available on registry
August 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
September 14, 2018
CompletedSeptember 14, 2018
August 1, 2018
1.2 years
August 26, 2008
August 14, 2017
August 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Subjective Marijuana Effects
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.
180 minutes after marijuana administration, during each of 8 outpatient sessions over the course of 3-6 weeks.
Study Arms (6)
Placebo naltrexone + Inactive marijuana
PLACEBO COMPARATORPlacebo naltrexone capsules (0mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order.
Placebo naltrexone + Active marijuana (5.5% THC)
PLACEBO COMPARATORPlacebo naltrexone capsules (0mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order.
Placebo naltrexone + Active marijuana (6.2% THC)
PLACEBO COMPARATORPlacebo naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order.
Naltrexone + Active marijuana (5.5% THC)
EXPERIMENTALNaltrexone capsules (12mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order.
Naltrexone + Active marijuana (6.2% THC)
EXPERIMENTALNaltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order.
Naltrexone + Inactive marijuana
PLACEBO COMPARATORNaltrexone capsules (12mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order.
Interventions
Marijuana cigarette containing 0% THC
Marijuana cigarette containing 5.5% THC
Marijuana cigarette containing 6.2% THC
Naltrexone (12mg/70kg)
Naltrexone (0mg)
Eligibility Criteria
You may qualify if:
- Current marijuana use
- Able to perform study procedures
- Women practicing an effective form of birth control
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York State Psychiatric Institute
New York, New York, 10032, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study is limited by its small sample size, and portion of males to females.
Results Point of Contact
- Title
- Margaret Haney, PhD
- Organization
- New York State Psychiatric Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Margaret Haney, Ph.D.
New York State Psychiatric Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-blind, placebo-controlled
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Psychaitrist
Study Record Dates
First Submitted
August 26, 2008
First Posted
August 28, 2008
Study Start
May 1, 2008
Primary Completion
July 1, 2009
Study Completion
September 1, 2009
Last Updated
September 14, 2018
Results First Posted
September 14, 2018
Record last verified: 2018-08