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

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ClinicalTrials.gov Identifier: NCT00743145
Recruitment Status : Completed
First Posted : August 28, 2008
Results First Posted : September 14, 2018
Last Update Posted : September 14, 2018
Sponsor:
Collaborators:
Research Foundation for Mental Hygiene, Inc.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Margaret Haney, New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Marijuana Smoking
Interventions Drug: Inactive Marijuana (0% THC)
Drug: Active Marijuana (5.5% THC)
Drug: Active Marijuana (6.2% THC)
Drug: Naltrexone
Drug: Placebo naltrexone
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo, Naltrexone, Marijuana
Hide Arm/Group Description A total of 23 participants enrolled but only 19 completed. All patients participated in all conditions; they were randomized to placebo or naltrexone treatment in a counterbalanced fashion, and underwent all smoking conditions in separate, counterbalanced sessions.
Period Title: Overall Study
Started 23
Completed 19
Not Completed 4
Reason Not Completed
Withdrawal by Subject             1
Adverse Event             2
Pregnancy             1
Arm/Group Title Placebo, Naltrexone, Marijuana
Hide Arm/Group Description During each of the 8 outpatient sessions, participants smoked a total of 6 puffs from 3 marijuana cigarettes (2 puffs from each cigarette). Marijuana administration occurred 45 minutes after capsule administration. The number of active versus inactive cigarettes smoked during each session varied, according to active puff conditions (i.e., 0 puffs = 3 inactive cigarettes; 2 puffs = 1 active + 2 inactive cigarette; 4 puffs = 2 active + 1 inactive cigarette; 6 puffs = 3 active + 0 inactive cigarette). Cigarettes were color coded, indicating the order in which they were to be smoked and active cigarettes were always smoked before inactive. A within-subject design was used in which all participants were exposed to each of the puff conditions in combination with naltrexone or placebo. The order of naltrexone dosing and puff condition was randomized within the session and across participants.
Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
19 participants completed the study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
<=18 years
0
   0.0%
Between 18 and 65 years
19
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants
27.0  (4.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
1
   5.3%
Male
18
  94.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
10
  52.6%
White
8
  42.1%
More than one race
0
   0.0%
Unknown or Not Reported
1
   5.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 19 participants
19
 100.0%
1.Primary Outcome
Title Subjective Marijuana Effects
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 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
Hide Arm/Group Description:

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

Inactive Marijuana (0% THC): Marijuana cigarette containing 0% THC

Placebo naltrexone: Naltrexone (0mg)

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

Active Marijuana (5.5% THC): Marijuana cigarette containing 5.5% THC

Placebo naltrexone: Naltrexone (0mg)

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

Active Marijuana (6.2% THC): Marijuana cigarette containing 6.2% THC

Placebo naltrexone: Naltrexone (0mg)

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

Active Marijuana (5.5% THC): Marijuana cigarette containing 5.5% THC

Naltrexone: Naltrexone (12mg/70kg)

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

Active Marijuana (6.2% THC): Marijuana cigarette containing 6.2% THC

Naltrexone: Naltrexone (12mg/70kg)

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

Inactive Marijuana (0% THC): Marijuana cigarette containing 0% THC

Naltrexone: Naltrexone (12mg/70kg)

Overall Number of Participants Analyzed 19 19 19 19 19 19
Mean (Standard Error)
Unit of Measure: units on a scale (0-100mm)
"Marijuana Strength" 13  (1) 15  (1) 16  (2) 16  (2) 20  (2) 16  (2)
"Marijuana Good Effect" 14  (2) 37  (3) 30  (2.5) 31  (3) 46  (2) 26  (2)
"Marijuana High" 10  (1) 10.5  (0.5) 10  (1) 11  (1.5) 16  (1.5) 10  (1.5)
"Marijuana Stimulation" 16  (2) 20  (2) 16  (2) 20  (1.5) 30  (2) 22  (2)
"Want Marijuana" 50  (1.5) 48  (1) 37  (1.5) 49  (1) 45  (1.5) 50  (1.5)
Time Frame 4 weeks for each treatment and 1 week after receiving last treatment.
Adverse Event Reporting Description Safety population included all participants who received at least one intervention. Research staff routinely asked participants to report any adverse events occurring during study sessions and during outpatient washout periods.
 
Arm/Group Title Placebo Naltrexone + Inactive Marijuana (0.0% THC) Placebo Naltrexone + Active Marijuana (5.5% THC) Placebo Naltrexone + Active Marijuana (6.2% THC) Naltrexone + Inactive Marijuana (0.0% THC) Naltrexone + Active Marijuana (5.5% THC) Naltrexone + Active Marijuana (6.2% THC)
Hide Arm/Group Description 0mg naltrexone + 0.0% THC marijuana 0mg naltrexone + 5.5% THC marijuana 0mg naltrexone + 6.2% THC marijuana 12mg naltrexone + 0.0% THC marijuana 12mg naltrexone + 5.5% THC marijuana 12mg naltrexone + 6.2% THC marijuana
All-Cause Mortality
Placebo Naltrexone + Inactive Marijuana (0.0% THC) Placebo Naltrexone + Active Marijuana (5.5% THC) Placebo Naltrexone + Active Marijuana (6.2% THC) Naltrexone + Inactive Marijuana (0.0% THC) Naltrexone + Active Marijuana (5.5% THC) Naltrexone + Active Marijuana (6.2% THC)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/23 (0.00%)   0/23 (0.00%)   0/23 (0.00%)   0/23 (0.00%)   0/23 (0.00%) 
Hide Serious Adverse Events
Placebo Naltrexone + Inactive Marijuana (0.0% THC) Placebo Naltrexone + Active Marijuana (5.5% THC) Placebo Naltrexone + Active Marijuana (6.2% THC) Naltrexone + Inactive Marijuana (0.0% THC) Naltrexone + Active Marijuana (5.5% THC) Naltrexone + Active Marijuana (6.2% THC)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/23 (0.00%)   0/23 (0.00%)   0/23 (0.00%)   0/23 (0.00%)   0/23 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Naltrexone + Inactive Marijuana (0.0% THC) Placebo Naltrexone + Active Marijuana (5.5% THC) Placebo Naltrexone + Active Marijuana (6.2% THC) Naltrexone + Inactive Marijuana (0.0% THC) Naltrexone + Active Marijuana (5.5% THC) Naltrexone + Active Marijuana (6.2% THC)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/23 (0.00%)   0/23 (0.00%)   0/23 (0.00%)   0/23 (0.00%)   0/23 (0.00%) 
This study is limited by its small sample size, and portion of males to females.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Margaret Haney, PhD
Organization: New York State Psychiatric Institute
Phone: 646-774-6153
EMail: mh235@cumc.columbia.edu
Layout table for additonal information
Responsible Party: Margaret Haney, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00743145    
Other Study ID Numbers: IRB# 5693
DA19239 ( Other Grant/Funding Number: National Institute on Drug Abuse (NIDA) )
First Submitted: August 26, 2008
First Posted: August 28, 2008
Results First Submitted: August 14, 2017
Results First Posted: September 14, 2018
Last Update Posted: September 14, 2018