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

This study has been completed.
Sponsor:
Collaborators:
Research Foundation for Mental Hygiene, Inc.
Information provided by:
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00743145
First received: August 26, 2008
Last updated: September 22, 2009
Last verified: September 2009
  Purpose

The purpose of this study is to determine how naltrexone shifts the marijuana-response curve, a single, low-dose of naltrexone (12 mg/70 kg) or placebo will be administered 45 minutes before smoking marijuana (0,2,4,6,puffs of 6.2% THC). Naltrexone (12 mg/70 kg) or placebo will be administered 45 minutes before smoking to assess how opioid receptor blockade affects marijuana's subjective and physiologic effects. It is predicted that increasing the number of puffs of active marijuana will increase positive subjective ratings of marijuana and naltrexone and further increase these ratings.


Condition Intervention Phase
Marijuana Smoking
Drug: Naltrexone
Drug: Smoked marijuana
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Effects of Low-dose Naltrexone in Combination With a Range of Smoked Marijuana

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Estimated Enrollment: 48
Study Start Date: May 2008
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Naltrexone
    12 mg/70kg
    Drug: Smoked marijuana
    0,2,4, or 6 puffs of 6.2% THC
Detailed Description:

Laboratory animal studies have convincingly demonstrated that opioid antagonists decrease the behavioral effects of cannabinoids. By contrast, in humans, the opioid antagonist naltrexone (12, 25, 50 and 100 mg) increases the subjective effects of a single strength of smoked marijuana (3.27% THC). A logical follow up to this finding is to determine how naltrexone shifts the marijuana-response curve. In the present study a single low dose of naltrexone (12 mg/70 kg, po) will be administered prior to a range of puffs of a marijuana cigarette (0, 2, 4, 6, puffs of 6.2% THC.) Non-treatment-seeking marijuana smokers will be recruited for an eight-session study during which the subjective, cognitive, and physiologic effects of smoked marijuana will be evaluated. Naltrexone (12 mg/70 kg, po) or placebo will be administered 45 minutes before smoking to assess how opioid receptor blockade effects marijuana's subjective and physiologic effects.

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743145

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Research Foundation for Mental Hygiene, Inc.
Investigators
Principal Investigator: Margaret Haney, Ph.D. New York State Psychiatric Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00743145     History of Changes
Other Study ID Numbers: 5693
Study First Received: August 26, 2008
Last Updated: September 22, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
naltrexone
smoked marijuana
marijuana use

Additional relevant MeSH terms:
Marijuana Abuse
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Naltrexone
Central Nervous System Agents
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014