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Effect of Quetiapine on Marijuana Withdrawal and Relapse

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:
NCT00743366
First received: August 26, 2008
Last updated: June 12, 2017
Last verified: June 2017
Results First Received: October 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Participant, Investigator;   Primary Purpose: Basic Science
Condition: Marijuana Smoking
Interventions: Drug: Marijuana
Drug: Quetiapine
Drug: Placebo oral capsule

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
14 volunteers completed the study (12 males; 2 females). An additional 6 volunteers enrolled (5 males, 1 female), but did not complete.

Reporting Groups
  Description
Quetiapine (200mg/Day), Placebo 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, Quetiapine (200mg/Day) 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).

Participant Flow for 2 periods

Period 1:   Intervention 1 (8 Days)
    Quetiapine (200mg/Day), Placebo   Placebo, Quetiapine (200mg/Day)
STARTED   10   10 
COMPLETED   7   7 
NOT COMPLETED   3   3 
Withdrawal by Subject                3                3 

Period 2:   Intervention 2 (8 Days)
    Quetiapine (200mg/Day), Placebo   Placebo, Quetiapine (200mg/Day)
STARTED   7   7 
COMPLETED   7   7 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Overall Number of Baseline Participants No text entered.

Baseline Measures
   Overall Number of Baseline Participants 
Overall Participants Analyzed 
[Units: Participants]
 14 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      14 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 26  (4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  14.3% 
Male      12  85.7% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   14 


  Outcome Measures

1.  Primary:   Measure of Relapse: Change in Puffs Chosen Between Baseline and Relapse Phase   [ Time Frame: Days 1-3 (Baseline) and Days 6-8 (Relapse Phase) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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:  
Name/Title: Dr. Ziva Cooper
Organization: New York State Psychiatric Institute
phone: 646-774-6129
e-mail: reslabsurc@gmail.com


Publications of Results:

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 )
Study First Received: August 26, 2008
Results First Received: October 20, 2016
Last Updated: June 12, 2017