Combined Treatment for Alcohol-Dependent Individuals With PTSD
2 other identifiers
interventional
69
1 country
1
Brief Summary
This treatment intervention trial is designed for men and women with either alcohol misuse (e.g. hazardous or binge drinking) or alcohol use disorders (alcohol abuse or dependence) and comorbid PTSD. Participants will be randomly assigned to one of two treatments (a cognitive behavioral treatment intervention called "Seeking Safety" + Medication ("Zoloft") or Seeking Safety + placebo) and will be evaluated at baseline, at completion of the treatment (12 sessions over 12 weeks), and again at 6 months and 12 months post-treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2006
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2005
CompletedFirst Posted
Study publicly available on registry
December 6, 2005
CompletedStudy Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
September 16, 2014
CompletedMarch 3, 2020
February 1, 2020
7.2 years
December 5, 2005
August 14, 2014
February 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Heavy Drinking Days/Week
Baseline, End-of-treatment, 6-month follow-up and 12-month follow-up
PTSD Symptom Severity / Clinician Administered PTSD Scale
Clinician Administered PTSD Scale (CAPS) is a 17-item, semi-structured interview of PTSD symptoms. Range of scores is 0-136. Five rationally derived severity score ranges for interpreting CAPS total score have been proposed: 0-19 = asymptomatic/few symptoms, 20-39 = mild PTSD/subthreshold, 40-59 = moderate PTSD/threshold, 60-79 = severe PTSD symptomatology, and \>80 = extreme PTSD symptomology (Weathers et. al., 2001). A 15-point change in CAPS total severity score has been proposed as a marker of clinically significant change (Weathers et. al., 2001).
Baseline, End-of-treatment, 6-month follow-up and 12-month follow-up
Study Arms (2)
1) Seeking Safety + Sertraline
ACTIVE COMPARATORSeeking Safety + Sertraline
2) Seeking Safety + Placebo
PLACEBO COMPARATORSeeking Safety + Placebo;
Interventions
Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders
An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type
Eligibility Criteria
You may qualify if:
- Males and females who are a minimum of 18 years and maximum of 65 years.
- Participants meet Diagnostic and Statistical Manual Diploma in Social Medicine IV (DSM-IV) criteria for current alcohol misuse, abuse or 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 or subthreshold PTSD. Subthreshold PTSD criteria differs from full PTSD in that the individual meets cluster C (numbing) OR cluster D (hyperarousal) whereas full PTSD requires that the individual meets both cluster C and D.
- Participants demonstrate no gross organic mental syndrome.
- Participants are capable of giving informed consent and capable of complying with study procedures.
- Participants speak English.
You may not qualify if:
- Individuals who are at significant risk for suicide based on their current mental state or history.
- Participants who are currently severely depressed.
- Participants with a history of psychosis or mania.
- Participants with organic mental syndrome.
- Participants physiologically dependent on any substance other than alcohol (excluding nicotine or caffeine or medically stable and managed methadone).
- Participants with comorbid substance abuse disorder who require detoxification treatment.
- Participants with unstable or significant physical disorders (e.g., uncontrolled hypertension, poorly-controlled diabetes, alanine aminotransferase/aspartate aminotransaminase (AST/ALT) three times the upper limit of normal) that would increase the risk of study participation.
- 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 that is contraindicated for use with sertraline (e.g. antidepressant medications except for mirtazapine or trazodone when used for the treatment of insomnia ) and/or psychotropic medications where the participant has not achieved a stabilized regimen. Participants that are stable on medications that are not contraindicated with the use of sertraline (e.g., Methadone or Adderall) will not be excluded.
- A 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
City College, City University of New York
New York, New York, 10031, United States
Related Publications (2)
Hien DA, Levin FR, Ruglass LM, Lopez-Castro T, Papini S, Hu MC, Cohen LR, Herron A. Combining seeking safety with sertraline for PTSD and alcohol use disorders: A randomized controlled trial. J Consult Clin Psychol. 2015 Apr;83(2):359-69. doi: 10.1037/a0038719. Epub 2015 Jan 26.
PMID: 25622199RESULTRuglass LM, Pedersen A, Cheref S, Hu MC, Hien DA. Racial differences in adherence and response to combined treatment for full and subthreshold post-traumatic stress disorder and alcohol use disorders: A secondary analysis. J Ethn Subst Abuse. 2016 Oct-Dec;15(4):434-448. doi: 10.1080/15332640.2015.1056927. Epub 2015 Sep 30.
PMID: 26422415RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Denise A. Hien, Ph.D.
- Organization
- The City College of New York
Study Officials
- PRINCIPAL INVESTIGATOR
Denise A. Hien, PhD
City College of New York & New York State Psychiatric Institute/Columbia University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 5, 2005
First Posted
December 6, 2005
Study Start
May 1, 2006
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
March 3, 2020
Results First Posted
September 16, 2014
Record last verified: 2020-02