CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 49 enrolled
Drug / intervention
Placebo + Inactive Marijuana (0% THC) +9 moredrug
Likely dose
Naltrexone 12 Mg+ Active Marijuana (3.27% THC)from 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/NCT00403117
NCT00403117Phase 2Completed
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Opioid Antagonism Enhances Marijuana's Effects in Heavy Marijuana Smokers

New York State Psychiatric Institute·interventional·Posted Nov 23, 2006·Updated Mar 15, 2018

In Brief

A Phase 2 clinical trial evaluating Placebo + Inactive Marijuana (0% THC), Placebo + Active Marijuana (3.27% THC), and 8 other interventions for Marijuana Use. Completed, enrolled 49 participants.

Detailed 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.

Study Details

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

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 23, 2006
Enrollment StartDec 1, 2006
Primary CompletionMay 1, 2008
Study CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 19.6 years ago

Interventions

Placebo + Inactive Marijuana (0% THC)drug

One capsule containing placebo was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration.

Placebo + Active Marijuana (3.27% THC)drug

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.

Naltrexone 12 Mg+ Active Marijuana (3.27% THC)drug

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.

Naltrexone 25 Mg + Active Marijuana (3.27% THC)drug

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.

Naltrexone 50 Mg+ Active Marijuana (3.27% THC)drug

One capsule containing 25mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration.

Naltrexone 100 Mg+ Active Marijuana (3.27% THC)drug

One capsule containing 50mg Naltrexone was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration.

Naltrexone 12 Mg + Inactive Marijuana (0% THC)drug

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.

Naltrexone 25 Mg + Inactive Marijuana (0% THC)drug

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.

Naltrexone 50 Mg + Inactive Marijuana (0% THC)drug

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.

Naltrexone 100 Mg + Inactive Marijuana (0% THC)drug

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.