Modifying Group Therapy for Bipolar Substance Abusers - 1

• Sponsor: National Institute on Drug Abuse (NIDA) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00227838
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Duration (Months): 25
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

The purpose of this study is to modify Integrated Group Therapy (IGT), which is has been found successful for patients with bipolar disorder (BD) and substance use disorder(SUD), so that it can be more readily adopted by community drug abuse treatment programs. IGT is being reduced from 20 to 12 sessions in this trial, and is being conducted by front-line drug counselors, to test its effectiveness in a more community-based setting. The training has been expanded so that counselors without much psychopathology training or cognitive behavioral therapy experience can conduct IGT.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder; Substance Dependence	Behavioral: Behavior Therapy	N/A

Detailed Description

IGT is being compared with 12 sessions of Group Drug Counseling (GDC) in a randomized controlled trial, with a sample size of 60 subjects. GDC is the type of treatment one would likely receive in a community drug abuse treatment program, in that it focuses primarily in substance use, unlike IGT, which focuses equally on SUD and BD issues. Patients are followed for a year after the end of the group therapy, to examine the long-term effects of the treatment, and also to examine the longer-term relationship of substance use and mood. Patients in the trial must be taking a mood stabilizer to enter the study. Any drug of abuse is accepted, and all subtypes of BD are accepted.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Modifying Group Therapy for Bipolar Abusers
• Study Start Date: Jul 1, 2003
• Actual Primary Completion Date: Jun 1, 2005
• Actual Study Completion Date: Aug 1, 2005

Outcome Measures

Primary Outcome Measures

1. Addiction severity []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• bipolar disorder substance dependence taking a mood stabilizer

Exclusion Criteria:

• acute psychosis no substance use in past 60 days no prescribing doctor will not be in area for next 15 months lives too far away

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McLean Hospital, Dept. of Psychiatry	Belmont	Massachusetts	United States	02478 9106

Sponsors and Collaborators

• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Roger Weiss, M.D., Mclean Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00227838
• Other Study ID Numbers: NIDA-15968-1; R01-15968-1
• First Posted: Sep 28, 2005
• Last Update Posted: Jan 12, 2017
• Last Verified: Sep 1, 2005

• Keywords provided by , ,: substance abuse
• Additional relevant MeSH terms: Substance-Related Disorders; Bipolar Disorder

Study Results

No Results Posted as of Jan 12, 2017