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

Marijuana Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743145
• Other study ID #: IRB# 5693
• Secondary ID: DA19239
• Status: Completed
• Phase: Phase 2
• Start date: May 2008
• Est. completion date: September 2009

Study information

• Verified date: August 2018
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Marijuana Abuse
• Marijuana Smoking

Intervention

Drug:
• Inactive Marijuana (0% THC)
Marijuana cigarette containing 0% THC
• Active Marijuana (5.5% THC)
Marijuana cigarette containing 5.5% THC
• Active Marijuana (6.2% THC)
Marijuana cigarette containing 6.2% THC
• Naltrexone
Naltrexone (12mg/70kg)
• Placebo naltrexone
Naltrexone (0mg)

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute on Drug Abuse (NIDA), Research Foundation for Mental Hygiene, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.