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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.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00743145
First received: August 26, 2008
Last updated: October 25, 2016
Last verified: October 2016
  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: marijuana
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
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:

Primary Outcome Measures:
  • subjective effects [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cardiovascular effects [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • cognitive effects [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: May 2008
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: naltrexone, marijuana
naltrexone (0, 12, 25, 50, 100 mg) marijuana (active, placebo)
Drug: Naltrexone
12 mg/70kg
Other Name: Revia
Drug: marijuana
0,2,4, or 6 puffs of 6.2% THC
Other Name: cannabis
Placebo Comparator: placebo, marijuana Drug: marijuana
0,2,4, or 6 puffs of 6.2% THC
Other Name: cannabis

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   (Adult)
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.
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Margaret Haney, Ph.D. New York State Psychiatric Institute
  More Information

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00743145     History of Changes
Other Study ID Numbers: 5693 
Study First Received: August 26, 2008
Last Updated: October 25, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on December 09, 2016