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

August 16, 2018 updated by: Margaret Haney, New York State Psychiatric Institute
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo naltrexone + Inactive marijuana
Placebo naltrexone capsules (0mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order.
Drug: Inactive Marijuana (0% THC)
Marijuana cigarette containing 0% THC
Other Names:
  • Cannabis
Drug: Placebo naltrexone
Naltrexone (0mg)
Other Names:
  • PBO
Placebo Comparator: Placebo naltrexone + Active marijuana (5.5% THC)
Placebo naltrexone capsules (0mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order.
Drug: Placebo naltrexone
Naltrexone (0mg)
Other Names:
  • PBO
Drug: Active Marijuana (5.5% THC)
Marijuana cigarette containing 5.5% THC
Other Names:
  • Cannabis
Placebo Comparator: Placebo naltrexone + Active marijuana (6.2% THC)
Placebo naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order.
Drug: Placebo naltrexone
Naltrexone (0mg)
Other Names:
  • PBO
Drug: Active Marijuana (6.2% THC)
Marijuana cigarette containing 6.2% THC
Other Names:
  • Cannabis
Experimental: Naltrexone + Active marijuana (5.5% THC)
Naltrexone capsules (12mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order.
Drug: Active Marijuana (5.5% THC)
Marijuana cigarette containing 5.5% THC
Other Names:
  • Cannabis
Drug: Naltrexone
Naltrexone (12mg/70kg)
Other Names:
  • Revia
Experimental: Naltrexone + Active marijuana (6.2% THC)
Naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order.
Drug: Active Marijuana (6.2% THC)
Marijuana cigarette containing 6.2% THC
Other Names:
  • Cannabis
Drug: Naltrexone
Naltrexone (12mg/70kg)
Other Names:
  • Revia
Placebo Comparator: Naltrexone + Inactive marijuana
Naltrexone capsules (12mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order.
Drug: Inactive Marijuana (0% THC)
Marijuana cigarette containing 0% THC
Other Names:
  • Cannabis
Drug: Naltrexone
Naltrexone (12mg/70kg)
Other Names:
  • Revia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
180 minutes after marijuana administration, during each of 8 outpatient sessions over the course of 3-6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

August 26, 2008

First Submitted That Met QC Criteria

August 26, 2008

First Posted (Estimate)

August 28, 2008

Study Record Updates

Last Update Posted (Actual)

September 14, 2018

Last Update Submitted That Met QC Criteria

August 16, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB# 5693
  • DA19239 (Other Grant/Funding Number: National Institute on Drug Abuse (NIDA))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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