CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
Inactive Marijuana (0% THC) +4 moredrug
Likely dose
Naltrexone 12mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00743145
NCT00743145Phase 2Completed
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Effects of Low-dose Naltrexone in Combination With a Range of Smoked Marijuana

New York State Psychiatric Institute·interventional·Posted Aug 28, 2008·Updated Sep 14, 2018

In Brief

A Phase 2 clinical trial evaluating Inactive Marijuana (0% THC), Active Marijuana (5.5% THC), and 3 other interventions for Marijuana Smoking. Completed, enrolled 23 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMarijuana Smoking
CountriesUnited States
CollaboratorsResearch Foundation for Mental Hygiene, Inc., National Institute on Drug Abuse (NIDA)

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 28, 2008
Enrollment StartMay 1, 2008
Primary CompletionJul 1, 2009
Study CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.8 years ago

Interventions

Inactive Marijuana (0% THC)drug

Marijuana cigarette containing 0% THC

Active Marijuana (5.5% THC)drug

Marijuana cigarette containing 5.5% THC

Active Marijuana (6.2% THC)drug

Marijuana cigarette containing 6.2% THC

Naltrexonedrug

Naltrexone (12mg/70kg)

Placebo naltrexonedrug

Naltrexone (0mg)