Combined Treatment for Alcohol-Dependent Women With PTSD - Full Text View

Sponsored by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:	NCT00262223

Purpose

The purpose of this study is to compare four different treatment conditions for women with comorbid alcohol dependence and Posttraumatic Stress Disorder (PTSD). We are comparing two behavioral treatments, Seeking Safety, a treatment that focuses on substance use and trauma-related issues and Twelve-Step Facilitation, a treatment designed to promote the individual's activity in traditional activities of Alcoholic Anonymous, alone and also in combination with the antidepressant medication sertraline ("Zoloft") in terms of their effectiveness in reducing alcohol use, psychiatric symptoms, and in increasing treatment participation.

Condition	Intervention	Phase
Stress Disorders, Post-Traumatic Alcohol Abuse Substance-Related Disorders	Drug: Sertraline ("Zoloft") Behavioral: Cognitive-behavioral treatment Drug: Placebo	Phase II

MedlinePlus related topics: Alcoholism Post-Traumatic Stress Disorder

Drug Information available for: Sertraline hydrochloride Sertraline Ethanol BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Combined Treatment for Alcohol-Dependent Women With PTSD

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:

Substance use severity [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
PTSD symptom severity [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
Global psychiatric severity [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
Retention rates in alcohol treatment [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Alcohol subtypes based on pre-morbid risk factors [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
Trajectory and trends of changes in substance use and PTSD symptoms [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	365
Study Start Date:	May 2006
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1) Seeking Safety + Sertraline: Active Comparator Seeking Safety + Sertraline	Drug: Sertraline ("Zoloft") Treating over a three month period with repeated measures at baseline, completion of treatment (3 months), 6-month and 12-month post-treatment follow-ups.
2) Seeking Safety + Placebo: Placebo Comparator Seeking Safety + Placebo;	Drug: Placebo Placebo
3) 12-Step + Sertraline: Active Comparator Twelve-Step Facilitation +Sertraline	Drug: Sertraline ("Zoloft") Treating over a three month period with repeated measures at baseline, completion of treatment (3 months), 6-month and 12-month post-treatment follow-ups. Behavioral: Cognitive-behavioral treatment Twelve-Step Facilitation over a three month period with repeated measures at baseline, completion of treatment (3 months), 6-month and 12-month post-treatment follow-ups.
4) 12-Step + Placebo: Placebo Comparator Twelve-Step Facilitation + Placebo	Behavioral: Cognitive-behavioral treatment Twelve-Step Facilitation over a three month period with repeated measures at baseline, completion of treatment (3 months), 6-month and 12-month post-treatment follow-ups. Drug: Placebo Placebo

Detailed Description:

The impetus for the current study is to contribute to the development of effective treatments targeted for women with comorbid alcohol dependence and PTSD. Research findings have shown that these women have poorer treatments outcomes and show more severe symptoms than treatment seeking alcohol-dependent participants without PTSD. The aim of this study is to replicate and expand on

pilot studies demonstrating the effectiveness of a manualized cognitive-behavioral treatment specifically designed for women with comorbid substance abuse disorders and PTSD, "Seeking Safety,"
preliminary results on the effectiveness of the antidepressant sertraline ("Zoloft") for a dually diagnosed population and
the examination of the effectiveness of a combination of these interventions over either treatment alone.

Our randomized, 4-armed clinical trial will assess the relative efficacy of 4 active treatments: Seeking Safety + Sertraline; Seeking Safety + Placebo; Twelve-Step Facilitation +Sertraline; Twelve-Step Facilitation + Placebo in treating urban women with alcohol dependence and comorbid PTSD over a three month period with repeated measures at baseline, completion of treatment (3 months), 6-month and 12-month post-treatment follow-ups.

The main outcomes to be examined in the present study are efficacy in: 1a) reducing alcohol drinks/drinking days and increasing abstinence; 1b) reducing PTSD symptom severity; 1c) reducing global psychiatric symptom severity; 1d) improving retention rates in alcohol treatment. Secondary aims of the study include exploring potential differences between alcoholic subtypes on treatment outcomes, and the trends of alcohol and drug use and PTSD symptom changes in each condition to determine any differences in the time course and order of changes.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Females who are a minimum of 18 years and maximum of 65 years.
Participants meet DSM-IV criteria for current alcohol dependence.
Participants must have current alcohol use over past 90 days defined by more than or equal to 2 heavy drinking days or more than or equal to 14 drinks over 30 consecutive days or abstinence less than or equal to 21 consecutive days.
Participants meet criteria for full PTSD.
Participants demonstrate no gross organic mental syndrome.
Participants are capable of giving informed consent and capable of complying with study procedures.
Participants speak English

Exclusion Criteria:

Participants are currently suicidal, or homicidal.
Participants who carry a current Axis-I diagnosis other than depressive, anxiety or adjustment disorders. Current diagnosis of Bipolar I and psychotic disorders are exclusionary.
Participants who are currently severely depressed.
Participants with a history of psychosis or mania.
Participants with organic mental syndrome
Participants with advanced stage medical disease (e.g., AIDS, TB) as indicated by global physical deterioration and incapacitation.
Participants with unstable physical disorders which might make antidepressant treatment hazardous examination such as uncontrolled hypertension, diabetes, heart disease, or hepatitis with transamine levels greater than three times the upper limit of normal.
Participants with a known history of seizures (not related to alcohol withdrawal).
Participants with moderate to severe alcohol withdrawal that would require pharmacological intervention.
Participants currently taking prescribed psychotropic medication.
Participants with a known history of an allergic reaction to sertraline.
Women who are currently pregnant or are trying to get pregnant or are nursing or are pre-menopausal and sexually active but not using effective birth control.
Participants refusing to be audio or videotaped.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262223

Contacts

Contact: Nathilee A. Caldeira, PhD	212-650-7821	nac2116@columbia.edu
Contact: Denise A. Hien, PhD	212-650-5666	Dah26@Columbia.edu

Locations

United States, New York
City College, City University of New York	Recruiting
New York, New York, United States, 10031
Contact: Nathilee A. Caldeira, PhD 212-650-7821 nac2116@columbia.edu
Contact: Lisa R. Cohen, Ph.D. lc2130@columbia.edu
Principal Investigator: Denise A. Hien, PhD
Women's Health Project, St. Luke's Rossevelt Hospital Center	Recruiting
New York, New York, United States, 10027
Contact: Denise A Hien, Ph.D. 212-750-5666 dah26@columbia.edu
Contact: Nathilee A Caldeira, Ph.D. 212-650-7821 nac2116@columbia.edu
Principal Investigator: Denise A. Hien, Ph.D.

Sponsors and Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:

Denise A. Hien, PhD

St. Luke's-Roosevelt Hospital Center

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	New York State Psychiatric Institute ( Denise Hien, Ph.D., Research Scientist and Professor )
Study ID Numbers:	NIAAAHIE014341, NIH grant AA014341
Study First Received:	December 5, 2005
Last Updated:	October 20, 2008
ClinicalTrials.gov Identifier:	NCT00262223
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Co-morbid alcohol dependence and PTSD
Trauma
Alcohol and other drug use disorders
Treatment outcome
Cognitive-behavioral treatment (CBT)

Twelve-Step Facilitation Therapy
Combination of anti-depressant medication and behavioral treatment
Post-traumatic Stress Disorder (PTSD)
Co-morbid Alcohol and other drug use disorders (AOD)

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Alcoholism
Wounds and Injuries
Substance-Related Disorders
Sertraline

Disorders of Environmental Origin
Stress Disorders, Post-Traumatic
Stress
Alcohol-Related Disorders
Stress Disorders, Traumatic
Ethanol

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 16, 2009