Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 90 of 450 for:    QUETIAPINE

Effect of Quetiapine on Marijuana Withdrawal and Relapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00743366
Recruitment Status : Completed
First Posted : August 28, 2008
Results First Posted : July 12, 2017
Last Update Posted : August 18, 2017
Sponsor:
Collaborators:
Research Foundation for Mental Hygiene, Inc.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
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: Marijuana
Drug: Quetiapine
Drug: Placebo oral capsule
Enrollment 20
Recruitment Details  
Pre-assignment Details 14 volunteers completed the study (12 males; 2 females). An additional 6 volunteers enrolled (5 males, 1 female), but did not complete.
Arm/Group Title Quetiapine (200mg/Day), Placebo Placebo, Quetiapine (200mg/Day)
Hide Arm/Group Description Quetiapine (200mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (200 mg) were administered 2 times per day (1100 and 2300 hours). Placebo medication (2x/day): Packaged riboflavin in size 00 opaque capsules to match size of active medication. Placebo capsules were administered 2 times per day (1100 and 2300 hours).
Period Title: Intervention 1 (8 Days)
Started 10 10
Completed 7 [1] 7 [1]
Not Completed 3 3
Reason Not Completed
Withdrawal by Subject             3             3
[1]
A total of 6 participants withdrew before completion of the final inpatient phase
Period Title: Intervention 2 (8 Days)
Started 7 7
Completed 7 7
Not Completed 0 0
Arm/Group Title Overall Number of Baseline Participants
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
26  (4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
2
  14.3%
Male
12
  85.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
 100.0%
1.Primary Outcome
Title Measure of Relapse: Change in Puffs Chosen Between Baseline and Relapse Phase
Hide Description

This is a measure of marijuana self-administration and relapse since each initial puff costs $10 and is a burden to overcome just to smoke.

Over each 3 day period, the puffs chosen by each participant is averaged for a single value.

Time Frame Days 1-3 (Baseline) and Days 6-8 (Relapse Phase)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine, Marijuana Placebo, Marijuana
Hide Arm/Group Description:

quetiapine's effects on marijuana withdrawal and relapse

Marijuana: 0,6.9% THC

Quetiapine: 0, 200 mg/day

[Not Specified]
Overall Number of Participants Analyzed 14 14
Mean (Standard Error)
Unit of Measure: Puffs
2.5  (0.6) 1.5  (1.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quetiapine (200mg/Day), Placebo Placebo, Quetiapine (200mg/Day)
Hide Arm/Group Description Quetiapine (200mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (200 mg) were administered 2 times per day (1100 and 2300 hours). Placebo medication (2x/day): Packaged riboflavin in size 00 opaque capsules to match size of active medication. Placebo capsules were administered 2 times per day (1100 and 2300 hours).
All-Cause Mortality
Quetiapine (200mg/Day), Placebo Placebo, Quetiapine (200mg/Day)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Quetiapine (200mg/Day), Placebo Placebo, Quetiapine (200mg/Day)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Quetiapine (200mg/Day), Placebo Placebo, Quetiapine (200mg/Day)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/20 (10.00%)      1/20 (5.00%)    
Gastrointestinal disorders     
gastrointestinal discomfort  [1]  2/20 (10.00%)  2 1/20 (5.00%)  1
Indicates events were collected by systematic assessment
[1]
gastrointestinal discomfort (nausea, vomiting, stomach pain, constipation).
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: Dr. Ziva Cooper
Organization: New York State Psychiatric Institute
Phone: 646-774-6129
EMail: reslabsurc@gmail.com
Layout table for additonal information
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00743366     History of Changes
Other Study ID Numbers: 5685
5P50DA009236 ( U.S. NIH Grant/Contract )
First Submitted: August 26, 2008
First Posted: August 28, 2008
Results First Submitted: October 20, 2016
Results First Posted: July 12, 2017
Last Update Posted: August 18, 2017