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AzTrials

Substance-Related DisordersPhase 3NCT00078156

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

A Phase 3 study testing Behavior Therapy in people with Substance-Related Disorders, run by New York State Psychiatric Institute at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 99 years, women only
Conditions the study is for
Substance-Related Disorders
What is being tested?
Behavior Therapy
How many people
409 participants
Where
7 sitesUnited States
Study dates
Jan 2004to Oct 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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).

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Addiction Research & Treatment Corp.-MSUCAS

    Brooklyn, New York, 11238

  • Addiction Research & Treatment Corp.-RISE

    Brooklyn, New York, 11238

  • Charleston Center

    Charleston, South Carolina, 29403

  • Maryhaven, Inc.

    Columbus, Ohio, 43207

  • Gateway Community Services

    Jacksonville, Florida, 32224

  • Residence XII

    Kirkland, Washington, 98034

  • The Villiage

    Miami, Florida, 33137

Other trials in United States

About this study

Official title: Women's Treatment for Trauma and Substance Use Disorders

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.

Being tested
Behavior Therapy
Keywords
behavioral intervention
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavior TherapyBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Drug abstinence

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2004 (estimated)
  2. Study startJan 2004
  3. Primary completionOct 2005
  4. Study completionOct 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Enrolment
409 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00078156
Sponsor's protocol ID
NIDA-CTN-0015-1
Status last verified
Oct 2016
First submitted
19 Feb 2004
Last updated
12 Jan 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 36696843

  • 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.

    PubMed 34138594

  • 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.

    PubMed 33175470

  • 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.

    PubMed 32853005

  • 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.

    PubMed 32664022

  • 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.

    PubMed 32608505

  • 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.

    PubMed 31804102

  • 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.

    PubMed 27739935

  • 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.

    PubMed 25735200

  • 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.

    PubMed 24724878

  • 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.

    PubMed 24313246

  • 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.

    PubMed 23558158

  • 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.

    PubMed 22182262

  • 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.

    PubMed 19917596

  • 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.

    PubMed 19634955

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Behavior Therapy in people with Substance-Related Disorders, run by New York State Psychiatric Institute at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Drug abstinence. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00078156, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.

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