Anxiety in Recovering Opiate Dependence

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. Identifier: NCT00668265
Recruitment Status : Terminated (The study was not completed, the funding sponsor lost interest.)
First Posted : April 29, 2008
Results First Posted : February 18, 2013
Last Update Posted : February 18, 2013
Information provided by (Responsible Party):
Beth Israel Medical Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Generalized Anxiety Disorder
Comorbid Opiate Dependence in Remission
Status Post Methadone-Maintenance Treatment
Intervention: Drug: Quetiapine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was initiated in 2007 adn terminated in 2010 due to PI's departure. All recrutiement took place at Su Casa residential treatment facility in New York City. All recruitment was done by the PI.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The subjects were individuals with opiate addiction on agonist therapy. After recruitement subjects underwent methadone taper as inpatients. Most subjects left the study because they signed out of the Su Casa Program and did not complete their methadone taper.

Reporting Groups
Quetiapine Arm

The participants were scheduled to receive Quetiapine, initially at a dose of 50 mg qHS for 2 days, followed by 100 mg qHS for 2 days, and then raised to a target dose of 150 mg qHS. Patients who do not tolerate that dose were titrated downwards in 50 mg increments until a tolerable dose is achieved. Medication dosage was further adjusted as necessary during the course of the study.

Concomitant Medications:

Concomitant psychotropic medications were not allowed. Concomitant medications for treatment of physical illnesses other than those indicated in the Exclusion Criteria were allowed

Placebo Arm The subjects in the placebo arm received inactive pills in identical blister packs

Participant Flow:   Overall Study
    Quetiapine Arm   Placebo Arm
STARTED   9   5 
COMPLETED   0 [1]   0 [1] 
[1] The PI left, no records avaialable; the number of subjects who completed the study is not known

  Baseline Characteristics

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
Quetiapine Subjects on MMTP receiving quetiapine
Placebo Subjects on methadone maintenance receiving placebo while inpatients in a methadone treatment facility Su Casa
Total Total of all reporting groups

Baseline Measures
   Quetiapine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   5   14 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   9   5   14 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 43  (7.0)   45  (9)   43.8  (9) 
[Units: Participants]
Female   2   1   3 
Male   7   4   11 
Region of Enrollment 
[Units: Participants]
United States   9   5   14 

  Outcome Measures

1.  Primary:   Hamilton Anxiety Scale at 16 Weeks   [ Time Frame: 16 weeks ]

2.  Secondary:   Beck Depression Inventory at 16 Weeks   [ Time Frame: 16 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Igor Galynker, MD
Organization: Beth Israel Medical Center
phone: 212 420 4535

Responsible Party: Beth Israel Medical Center Identifier: NCT00668265     History of Changes
Other Study ID Numbers: IRB # (112-07)
First Submitted: April 28, 2008
First Posted: April 29, 2008
Results First Submitted: October 19, 2012
Results First Posted: February 18, 2013
Last Update Posted: February 18, 2013