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Completed

NCT Number: NCT00743145

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

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.

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Key information

Conditions

Marijuana Smoking Behavior Marijuana Use Mental Disorders Smoking Smoking, Non-Tobacco Products Substance-Related Disorders

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New York State Psychiatric Institute

New York, 10032, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inactive marijuana (0% THC)

Drug

Marijuana cigarette containing 0% THC

Other names: Cannabis

Active Marijuana (5.5% THC)

Drug

Marijuana cigarette containing 5.5% THC

Other names: Cannabis

Active Marijuana (6.2% THC)

Drug

Marijuana cigarette containing 6.2% THC

Other names: Cannabis

Naltrexone

Drug

Naltrexone (12mg/70kg)

Other names: Revia

Placebo Naltrexone

Drug

Naltrexone (0mg)

Other names: PBO

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • Research Foundation for Mental Hygiene, Inc.

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 28, 2008
Registry last updated
Sep 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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