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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00622921
Other study ID # 0711003228
Secondary ID 0711003228
Status Withdrawn
Phase Phase 2/Phase 3
First received
Last updated
Start date February 2008
Est. completion date February 2012

Study information

Verified date March 2020
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Purpose: Phase I focus groups with clinicians and patients will gather qualitative data to focus and inform the content of Phase II. In Phase II, 12 weeks of psychotherapy will be offered to evaluate feasibility and potential efficacy of a couples-based, integrated treatment for men with PTSD and alcohol dependence.

Hypotheses: We predict that this experimental psychotherapy, Partners Encouraging Abstinence and Coping with Emotions (PEACE), will reduce patient drinking, reduce PTSD symptoms, and improve relationship functioning.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Male
Age group 21 Years to 65 Years
Eligibility Inclusion Criteria:

- Male patients

- One to six weeks of abstinence from alcohol and other drugs

- Both partners agree to stated goals of abstinence from alcohol and drugs, reduction of PTSD symptoms, and relationship improvement

- Current diagnoses of both alcohol dependence and PTSD

- Receiving treatment for one or both disorders

- Functionally able to participate in outpatient treatment as determined by P.I. "Functionally able" includes access to transportation.

- Alcohol is "drug of choice" (History of other drugs acceptable)

- Married or cohabiting in stable relationship for at least 6 months. Separated couples may participate if attempting to reconcile

- Patient willing to sign release of information allowing researchers to communicate with patient's clinician regarding treatment goals

Exclusion Criteria:

- Spouse or partner also has an alcohol or drug problem as determined by P.I. based on report by patient or partner or as revealed on Alcohol Use Disorders Identification Test (AUDIT) or the Drug Abuse Screening Test (DAST) given to partner at intake assessment

- Mental retardation or learning disorder by clinician report or patient chart

- Psychotic disorder as determined by patient's chart or SCID

- Patient currently receiving methadone or another opiate agonist by patient report or chart

- Current fear of partner or history of severe domestic violence in the past year. An example of severe violence would be a couple reporting an episode of violence that required medical attention. Such couples will be excluded from the study and referred to domestic violence treatment. Couples who have experienced mild to moderate domestic violence may participate in Phase II of the study.

Study Design


Intervention

Behavioral:
Couples-based behavioral psychotherapy
12 weeks of Couples-based behavioral psychotherapy

Locations

Country Name City State
United States VA Connecticut Healthcare System West Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary PTSD symptoms, Alcohol use 12 weeks
Secondary relationship functioning 12 weeks
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