Women's Treatment for Trauma and Substance Use Disorders - 1

NCT ID: NCT00078156

Last Updated: 2017-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

409 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2005-10-31

Brief Summary

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The purpose of this study is to compare the effectiveness of adding Seeking Safety to standard substance abuse treatment to adding a control condition: Women's Health Education to standard substance abuse treatment.

Detailed Description

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Conditions

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Substance-Related Disorders

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Behavior Therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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Exclusion Criteria

\- Women will be excluded from the study who have current psychotic disorders, or a history of active psychosis (past two months); women with a diagnosis of substance abuse or dependence who also have either full or sub-threshold DSM-IV PTSD; and women who have current psychotic disorders, or a history of active psychosis (past two months).
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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New York State Psychiatric Institute

Principal Investigators

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Denise Hien, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

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Gateway Community Services

Jacksonville, Florida, United States

Site Status

The Villiage

Miami, Florida, United States

Site Status

Addiction Research & Treatment Corp.-MSUCAS

Brooklyn, New York, United States

Site Status

Addiction Research & Treatment Corp.-RISE

Brooklyn, New York, United States

Site Status

Maryhaven, Inc.

Columbus, Ohio, United States

Site Status

Charleston Center

Charleston, South Carolina, United States

Site Status

Residence XII

Kirkland, Washington, United States

Site Status

Countries

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United States

References

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Ruglass LM, Shevorykin A, Zhao Y, Killeen TK, Bauer AG, Morgan-Lopez AA, Back SE, Fitzpatrick S, Lopez-Castro T, Norman SB, Saavedra LM, Hien DA. Self-report and urine drug screen concordance among women with co-occurring PTSD and substance use disorders participating in a clinical trial: Impact of drug type and participant characteristics. Drug Alcohol Depend. 2023 Mar 1;244:109769. doi: 10.1016/j.drugalcdep.2023.109769. Epub 2023 Jan 14.

Reference Type DERIVED
PMID: 36696843 (View on PubMed)

Fitzpatrick SS, Morgan-Lopez AA, Saraiya TC, Back SE, Killeen TK, Norman SB, Lopez-Castro T, Ruglass LM, Saavedra LM, Hien DA. Graded response item response theory in scaling suicidal thoughts and behaviors among trauma-exposed women with substance use disorders. Psychol Addict Behav. 2022 Jun;36(4):397-409. doi: 10.1037/adb0000757. Epub 2021 Jun 17.

Reference Type DERIVED
PMID: 34138594 (View on PubMed)

Saavedra LM, Morgan-Lopez AA, Hien DA, Killeen TK, Back SE, Ruglass LM, Fitzpatrick S, Lopez-Castro T. Putting the Patient Back in Clinical Significance: Moderated Nonlinear Factor Analysis for Estimating Clinically Significant Change in Treatment for Posttraumatic Stress Disorder. J Trauma Stress. 2021 Apr;34(2):454-466. doi: 10.1002/jts.22624. Epub 2020 Nov 11.

Reference Type DERIVED
PMID: 33175470 (View on PubMed)

Ruglass LM, Morgan-Lopez AA, Saavedra LM, Hien DA, Fitzpatrick S, Killeen TK, Back SE, Lopez-Castro T. Measurement nonequivalence of the Clinician-Administered PTSD Scale by race/ethnicity: Implications for quantifying posttraumatic stress disorder severity. Psychol Assess. 2020 Nov;32(11):1015-1027. doi: 10.1037/pas0000943. Epub 2020 Aug 27.

Reference Type DERIVED
PMID: 32853005 (View on PubMed)

Morgan-Lopez AA, Killeen TK, Saavedra LM, Hien DA, Fitzpatrick S, Ruglass LM, Back SE. Crossover between diagnostic and empirical categorizations of full and subthreshold PTSD. J Affect Disord. 2020 Sep 1;274:832-840. doi: 10.1016/j.jad.2020.05.031. Epub 2020 May 24.

Reference Type DERIVED
PMID: 32664022 (View on PubMed)

Hameed M, O'Doherty L, Gilchrist G, Tirado-Munoz J, Taft A, Chondros P, Feder G, Tan M, Hegarty K. Psychological therapies for women who experience intimate partner violence. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013017. doi: 10.1002/14651858.CD013017.pub2.

Reference Type DERIVED
PMID: 32608505 (View on PubMed)

Morgan-Lopez AA, Saavedra LM, Hien DA, Killeen TK, Back SE, Ruglass LM, Fitzpatrick S, Lopez-Castro T, Patock-Peckham JA. Estimation of equable scale scores and treatment outcomes from patient- and clinician-reported PTSD measures using item response theory calibration. Psychol Assess. 2020 Apr;32(4):321-335. doi: 10.1037/pas0000789. Epub 2019 Dec 5.

Reference Type DERIVED
PMID: 31804102 (View on PubMed)

Resko SM, Brown S, Mendoza NS, Crosby S, Gonzalez-Prendes A. Perceived Treatment Needs Among Women With Co-occurring Substance Use Disorders and PTSD. J Dual Diagn. 2016 Jul-Dec;12(3-4):271-281. doi: 10.1080/15504263.2016.1248309. Epub 2016 Oct 14.

Reference Type DERIVED
PMID: 27739935 (View on PubMed)

Lopez-Castro T, Hu MC, Papini S, Ruglass LM, Hien DA. Pathways to change: Use trajectories following trauma-informed treatment of women with co-occurring post-traumatic stress disorder and substance use disorders. Drug Alcohol Rev. 2015 May;34(3):242-51. doi: 10.1111/dar.12230. Epub 2015 Mar 4.

Reference Type DERIVED
PMID: 25735200 (View on PubMed)

Morgan-Lopez AA, Saavedra LM, Hien DA, Campbell AN, Wu E, Ruglass L, Patock-Peckham JA, Bainter SC. Indirect effects of 12-session seeking safety on substance use outcomes: overall and attendance class-specific effects. Am J Addict. 2014 May-Jun;23(3):218-25. doi: 10.1111/j.1521-0391.2014.12100.x.

Reference Type DERIVED
PMID: 24724878 (View on PubMed)

Ruglass LM, Hien DA, Hu MC, Campbell AN. Associations between post-traumatic stress symptoms, stimulant use, and treatment outcomes: a secondary analysis of NIDA's Women and Trauma study. Am J Addict. 2014 Jan-Feb;23(1):90-5. doi: 10.1111/j.1521-0391.2013.12068.x. Epub 2013 Jun 26.

Reference Type DERIVED
PMID: 24313246 (View on PubMed)

Morgan-Lopez AA, Saavedra LM, Hien DA, Campbell AN, Wu E, Ruglass L. Synergy between seeking safety and twelve-step affiliation on substance use outcomes for women. J Subst Abuse Treat. 2013 Aug;45(2):179-89. doi: 10.1016/j.jsat.2013.01.015. Epub 2013 Apr 1.

Reference Type DERIVED
PMID: 23558158 (View on PubMed)

Hien DA, Morgan-Lopez AA, Campbell AN, Saavedra LM, Wu E, Cohen L, Ruglass L, Nunes EV. Attendance and substance use outcomes for the Seeking Safety program: sometimes less is more. J Consult Clin Psychol. 2012 Feb;80(1):29-42. doi: 10.1037/a0026361. Epub 2011 Dec 19.

Reference Type DERIVED
PMID: 22182262 (View on PubMed)

Hien DA, Jiang H, Campbell AN, Hu MC, Miele GM, Cohen LR, Brigham GS, Capstick C, Kulaga A, Robinson J, Suarez-Morales L, Nunes EV. Do treatment improvements in PTSD severity affect substance use outcomes? A secondary analysis from a randomized clinical trial in NIDA's Clinical Trials Network. Am J Psychiatry. 2010 Jan;167(1):95-101. doi: 10.1176/appi.ajp.2009.09091261. Epub 2009 Nov 16.

Reference Type DERIVED
PMID: 19917596 (View on PubMed)

Hien DA, Wells EA, Jiang H, Suarez-Morales L, Campbell AN, Cohen LR, Miele GM, Killeen T, Brigham GS, Zhang Y, Hansen C, Hodgkins C, Hatch-Maillette M, Brown C, Kulaga A, Kristman-Valente A, Chu M, Sage R, Robinson JA, Liu D, Nunes EV. Multisite randomized trial of behavioral interventions for women with co-occurring PTSD and substance use disorders. J Consult Clin Psychol. 2009 Aug;77(4):607-19. doi: 10.1037/a0016227.

Reference Type DERIVED
PMID: 19634955 (View on PubMed)

Hien DA, Campbell AN, Killeen T, Hu MC, Hansen C, Jiang H, Hatch-Maillette M, Miele GM, Cohen LR, Gan W, Resko SM, DiBono M, Wells EA, Nunes EV. The impact of trauma-focused group therapy upon HIV sexual risk behaviors in the NIDA Clinical Trials Network "Women and trauma" multi-site study. AIDS Behav. 2010 Apr;14(2):421-30. doi: 10.1007/s10461-009-9573-7. Epub 2009 May 19.

Reference Type DERIVED
PMID: 19452271 (View on PubMed)

Other Identifiers

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NIDA-CTN-0015-1

Identifier Type: -

Identifier Source: org_study_id

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