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

NCT00743145 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2018-09-14

Study results available
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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.

Conditions

  • Marijuana Smoking

Interventions

DRUG

Inactive Marijuana (0% THC)

Marijuana cigarette containing 0% THC

DRUG

Active Marijuana (5.5% THC)

Marijuana cigarette containing 5.5% THC

DRUG

Active Marijuana (6.2% THC)

Marijuana cigarette containing 6.2% THC

DRUG

Naltrexone

Naltrexone (12mg/70kg)

DRUG

Placebo naltrexone

Naltrexone (0mg)

Sponsors & Collaborators

  • Research Foundation for Mental Hygiene, Inc.

    collaborator OTHER
  • National Institute on Drug Abuse (NIDA)

    collaborator NIH
  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • Margaret Haney, Ph.D. · New York State Psychiatric Institute

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-07-31
Completion
2009-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00743145 on ClinicalTrials.gov