Official Title: “Recovery Group for Women With Substance Use Disorders”

The purpose of this study is to develop a 12-session, manual-based relapse prevention group for women with substance use disorders (SUDs). The treatment manual for a Women's Recovery Group (WRG) will focus on the themes that are relevant to women with SUDs. There will be an emphasis on educating patients about treatment and relapse prevention in a context that is relevant to women. The manual will combine therapist information and instructions with patient worksheets, handouts and homework assignments. The treatment intervention will be conducted twice in a pre-pilot study led by study investigators. The investigators will then conduct a pilot study in which outcomes among subjects receiving the treatment intervention will be compared with outcomes of subjects who receive "treatment as usual". The study hypothesis is that the treatment intervention, when fully developed, will reduce substance use and lengthen time to relapse to substance in this population of women.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Behavioral: Behavior Therapy

Primary Measures

• Drug and alcohol use

Inclusion Criteria:

• (a) are age 18-65; (b) meet current DSM-IV criteria for substance dependence and have used substances within the previous 60 days; (c) plan to stay in the Boston area for the duration of the study period; (d) consent for us to communicate with any other mental health prodessional from whom they are receiving care; (e) furnish the names of at least two locators, who will assist the study personnel in locating them during the study period;
• (f) are interested in group treatment; (g) live close enough to McLean Hospital to come to a group weekly; (h) are able to sign informed consent; (i) have another mental health clinician if they have another Axis I or Axis II disorder that requires treatment

Exclusion Criteria:

• (a) have a current medical condition that would prevent regular group attendance; (b) have mental retardation or organic mental disorder; (c) have other major Axis I psychiatric disorders according to DSM-IV such as psychotic disorders and bipolar disorder; (d) are mandated to treatment; (e) are currently in residential treatment setting in which substance use is monitored and restricted; (f) currently require medical detoxification

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Shelly F Greenfield, M.D., M.P.H. Principal Investigator Mclean Hospital  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00230100

Study ID Number: NIDA-15434-1

ClinicalTrials.gov Identifier: NCT00230100

Health Authority: United States: Federal Government