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

Primary Purpose

Marijuana Smoking

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Inactive Marijuana (0% THC)
Active Marijuana (5.5% THC)
Active Marijuana (6.2% THC)
Naltrexone
Placebo naltrexone
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Marijuana Smoking focused on measuring naltrexone, smoked marijuana, marijuana use

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Placebo Comparator

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Arm Label

Placebo naltrexone + Inactive marijuana

Placebo naltrexone + Active marijuana (5.5% THC)

Placebo naltrexone + Active marijuana (6.2% THC)

Naltrexone + Active marijuana (5.5% THC)

Naltrexone + Active marijuana (6.2% THC)

Naltrexone + Inactive marijuana

Arm Description

Placebo naltrexone capsules (0mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order.

Placebo naltrexone capsules (0mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order.

Placebo naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order.

Naltrexone capsules (12mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order.

Naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order.

Naltrexone capsules (12mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 26, 2008
Last Updated
August 16, 2018
Sponsor
New York State Psychiatric Institute
Collaborators
Research Foundation for Mental Hygiene, Inc., National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00743145
Brief Title
Effects of Low-dose Naltrexone in Combination With a Range of Smoked Marijuana
Official Title
Effects of Low-dose Naltrexone in Combination With a Range of Smoked Marijuana
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
Research Foundation for Mental Hygiene, Inc., National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Smoking
Keywords
naltrexone, smoked marijuana, marijuana use

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blind, placebo-controlled
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo naltrexone + Inactive marijuana
Arm Type
Placebo Comparator
Arm Description
Placebo naltrexone capsules (0mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order.
Arm Title
Placebo naltrexone + Active marijuana (5.5% THC)
Arm Type
Placebo Comparator
Arm Description
Placebo naltrexone capsules (0mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order.
Arm Title
Placebo naltrexone + Active marijuana (6.2% THC)
Arm Type
Placebo Comparator
Arm Description
Placebo naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order.
Arm Title
Naltrexone + Active marijuana (5.5% THC)
Arm Type
Experimental
Arm Description
Naltrexone capsules (12mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order.
Arm Title
Naltrexone + Active marijuana (6.2% THC)
Arm Type
Experimental
Arm Description
Naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order.
Arm Title
Naltrexone + Inactive marijuana
Arm Type
Placebo Comparator
Arm Description
Naltrexone capsules (12mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order.
Intervention Type
Drug
Intervention Name(s)
Inactive Marijuana (0% THC)
Other Intervention Name(s)
Cannabis
Intervention Description
Marijuana cigarette containing 0% THC
Intervention Type
Drug
Intervention Name(s)
Active Marijuana (5.5% THC)
Other Intervention Name(s)
Cannabis
Intervention Description
Marijuana cigarette containing 5.5% THC
Intervention Type
Drug
Intervention Name(s)
Active Marijuana (6.2% THC)
Other Intervention Name(s)
Cannabis
Intervention Description
Marijuana cigarette containing 6.2% THC
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Other Intervention Name(s)
Revia
Intervention Description
Naltrexone (12mg/70kg)
Intervention Type
Drug
Intervention Name(s)
Placebo naltrexone
Other Intervention Name(s)
PBO
Intervention Description
Naltrexone (0mg)
Primary Outcome Measure Information:
Title
Subjective Marijuana Effects
Description
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.
Time Frame
180 minutes after marijuana administration, during each of 8 outpatient sessions over the course of 3-6 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Haney, Ph.D.
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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

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