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N/A N=66 Randomized Single-blind Treatment

Women Veterans' Substance Abuse Treatment

Substance Use Disorders

Enrolled (actual)
66
Serious AEs
16.7%
Results posted
Nov 2018
Primary outcome: Primary: Addiction Severity Index Alcohol Composite — .36; .46; .18; .26 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
A Woman's Path to Recovery (Behavioral); 12-Step Facilitation (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
VA Office of Research and Development
Primary completion
Mar 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Addiction Severity Index Alcohol Composite
.36; .46; .18; .26; .23; .21
PRIMARY
Addiction Severity Index Drug Composite
.10; .10; .04; .06; .04; .04
PRIMARY
Brief Addiction Monitor
4.61; 4.48; 1.96; 2.33; 2.33; 1.92
SECONDARY
Addiction Severity Index Medical Composite Score
.38; .43; .38; .33; .21; .20
SECONDARY
Addiction Severity Index Employment Composite
.64; .59; .58; .54; .58; .56
SECONDARY
Addiction Severity Index Psychiatric Composite
.43; .48; .37; .41; .31; .39
SECONDARY
Addiction Severity Index Family/Social Composite
.20; .29; .14; .22; .23; .30
SECONDARY
Global Severity Index of the Brief Symptom Inventory
1.55; 1.85; 1.37; 1.34; 1.62; 1.26
SECONDARY
BASIS-24 Psychosocial Functioning
36.22; 38.05; 33.40; 34.12; 29.80; 29.57
SECONDARY
Coping Skills Measure
2.25; 2.92; 2.88; 2.95; 2.85; 2.92
SECONDARY
Alcoholics Anonymous (AA) Intention Measure
5.21; 5.26; 4.90; 4.97; 4.99; 4.97

Summary

The purpose of this study is to examine the efficacy of a gender-focused addiction treatment model (A Woman's Path to Recovery) versus a non-gender focused addiction treatment model (12-Step Facilitation) in a sample of women Veterans with substance use disorder.

Eligibility Criteria

Inclusion Criteria

  • Female Veteran
  • 18-65 years of age
  • Meet DSM-IV criteria for current SUD with "current" defined as meeting SUD criteria per the DSM-IV and having used a substance within the 90 days prior to intake (to be able to accurately evaluate changes in their substance use from baseline)
  • Plan to stay in the Boston area for the next 6 months
  • Have a mailing address and live close enough to come to the hospital once weekly for treatment and/or assessment
  • Able to complete the Statement of Informed Consent
  • Willing to participate in all assessments and breathalyzer/urine testing
  • Willing to provide a release of information such that study staff can contact her other providers as needed regarding any concerns during her participation
  • Able to obtain medical clearance
  • Willing to allow us to contact family and/or friends if participant loses contact with us
  • Literate
  • Not pregnant or planning to become pregnant

Exclusion Criteria

  • Any acute medical condition that would interfere with the participant's ability to participate in treatment, or would be of such severity as to affect the individual's psychological functioning (e.g., cancer)
  • Current bipolar I disorder, schizophrenia or other psychotic disorders or mental retardation or organic mental disorder (determined by screening interview)
  • Any clinical sign that the client is not sufficiently stable to participate in the treatment, such as client's treatment provider indicating that participation in the treatment would be contraindicated
  • Dangerousness that would present a threat to other staff or other clients (e.g., history of recent assault)
  • Client is mandated to treatment
  • Psychopharmacologic treatment that is planned to change or likely to change substantively over the 3-month active treatment phase (with "substantive" defined as any addition of a new medication or major shift in dosage)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00734903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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