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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA014341-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
The impetus for the current study is to contribute to the development of effective treatments targeted for men and women with either alcohol misuse (e.g., hazardous or binge drinking) or alcohol use disorders (e.g. alcohol abuse or alcohol dependence) and comorbid PTSD. Research findings have shown that these individuals have poorer treatment outcomes and show more severe symptoms than treatment seeking alcohol-misusing or alcohol dependent participants without PTSD. The aim of this study is to replicate and expand on 1) pilot studies demonstrating the effectiveness of a manualized cognitive-behavioral treatment specifically designed for individuals with comorbid substance use disorders and PTSD, "Seeking Safety" 2) preliminary results on the effectiveness of the antidepressant sertraline ("Zoloft") for a dually diagnosed population and 3) the examination of the effectiveness of these interventions over either treatment alone. We are comparing "Seeking Safety" alone to "Seeking Safety" in combination with the antidepressant medication sertraline ("Zoloft") in terms of their effectiveness in reducing alcohol use and PTSD symptoms. Participants will be randomly assigned to one of two treatments (Seeking Safety + Med 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. Secondary aims of the study include exploring potential differences between alcoholic subtypes on treatment outcomes; impact of combined treatment on treatment participation and global psychiatric symptoms; differences in the time course and order of changes in alcohol and drug use and PTSD symptoms by condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1) Seeking Safety + Sertraline | Active Comparator | Seeking Safety + Sertraline |
|
| 2) Seeking Safety + Placebo | Placebo Comparator | Seeking Safety + Placebo; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seeking Safety | Behavioral | Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denise A. Hien, PhD | City College of New York & New York State Psychiatric Institute/Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City College, City University of New York | New York | New York | 10031 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25622199 | Result | 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. | |
| 26422415 | Result | Ruglass 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. |
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Individuals were screened through a brief telephone interview and then completed a baseline interview. After baseline assessment and medical clearance, eligible participants began a one-week, single-blind placebo lead-in phase. Those who completed the lead in phase were accepted into the study.
Participants in the metropolitan New York area were recruited through newspaper and radio advertisements, flyers, and referrals from outpatient mental health centers between April 2006 and March 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1) Seeking Safety + Sertraline | Seeking Safety + Sertraline Seeking Safety: Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders Sertraline: An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type |
| FG001 | 2) Seeking Safety + Placebo | Seeking Safety + Placebo; Seeking Safety: Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders Sertraline: An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Phase |
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| 1-week Post-treatment Follow-up |
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| 6-month Post-treatment Follow-up |
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| 12-month Post-treatment Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1) Seeking Safety + Sertraline | Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders + Setraline, an anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type |
| BG001 | 2) Seeking Safety + Placebo |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Heavy Drinking Days/Week | Posted | Mean | Standard Deviation | Days/Week | Baseline, End-of-treatment, 6-month follow-up and 12-month follow-up |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Seeking Safety + Sertraline | Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders, + Setraline, an anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious medical illness | General disorders | Serious medical incidents were reported to the study's institutional review boards and none were determined to be study-related. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Denise A. Hien, Ph.D. | The City College of New York | (212) 650-5666 | dhien@ccny.cuny.edu |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D000437 | Alcoholism |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D019973 | Alcohol-Related Disorders |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
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| Sertraline | Drug | An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type |
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| Pill placebo | Drug |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders + Pill placebo |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline, End-of-treatment, 6-month follow-up and 12-month follow-up |
|
|
|
|
| 1 |
| 32 |
| 0 |
| 32 |
| EG001 | Seeking Seeking + Placebo | Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders + Pill Placebo | 2 | 37 | 0 | 37 |
|
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| D064419 | Chemically-Induced Disorders |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| 6-month |
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| 12-month |
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| Superiority or Other (legacy) |