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Anxiety Sensitivity Treatment for Heroin Users (ASTH-HR)

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ClinicalTrials.gov Identifier: NCT01196312
Recruitment Status : Unknown
Verified September 2010 by University of Maryland.
Recruitment status was:  Recruiting
First Posted : September 8, 2010
Last Update Posted : September 8, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
Anxiety Sensitivity Treatment for Heroin Users is a development project targeting mild and above levels of anxiety sensitivity that will involve the testing of a specialized protocol for improving treatment retention and outcomes for heroin dependent individuals in a residential substance use treatment. ASTH-HR will integrate established treatment modules such as Healthy Relationships, along with interoceptive exposure, affect management, and psycho-education exercises developed for anxiety prevention and treatment programs with standard substance use treatment.

Condition or disease Intervention/treatment
Anxiety Behavioral: Anxiety sensitivity therapy

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Novel Intervention for Drug Use and HIV Risk Among Anxiety Sensitive Heroin Users
Study Start Date : October 2009
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Anxiety
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Behavioral: Anxiety sensitivity therapy
    ASTH consists of 6 sessions of individual treatment, each lasting approximately 75 minutes over 3 weeks. In general, each session consists of the following components1) psychoeducation regarding the anxiety response, with a focus on increasing awareness of the ways in which the patient interprets or evaluates that response 2) assistance in developing healthy emotion regulation strategies that can be used to increase acceptance and tolerance of the anxiety response (including associated catastrophic thoughts), as well as understanding the consequences associated with avoidance or control of anxiety 3) a minimum of 3 interoceptive exercises tailored to activate feared anxiety-related sensations and 4) daily homework assignments (i.e., daily anxiety monitoring and interoceptive exercises).

Outcome Measures

Primary Outcome Measures :
  1. Anxiety Sensitivity Index-3 [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Timeline Follow Back 90 days [ Time Frame: 24 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • exhibit a score of 21 on a self-report measure of anxiety sensitivity
  • be in 28 days of residential substance use treatment.
  • meet criteria for current opioid dependence as determined by SCID interview administered at intake.

Exclusion Criteria:

  • evidence of limited mental competency
  • the inability to give informed, voluntary, written consent to participate
  • current psychosis
  • current bipolar disorder.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01196312


Contacts
Contact: Carl W Lejuez, PhD (301)405-5932 clejuez@psyc.umd.edu

Locations
United States, District of Columbia
Salvation Army Harbor Light Treatment Facilitiy Recruiting
Washington, District of Columbia, United States, 20002
Contact    202-269-6333      
Principal Investigator: Carl Lejuez, PhD         
Sponsors and Collaborators
University of Maryland
More Information

Responsible Party: Dr. Carl W. Lejuez, Department of Psychology University Of Maryland, College Park
ClinicalTrials.gov Identifier: NCT01196312     History of Changes
Other Study ID Numbers: DA023384
First Posted: September 8, 2010    Key Record Dates
Last Update Posted: September 8, 2010
Last Verified: September 2010

Keywords provided by University of Maryland:
anxiety sensitivity
heroin

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Heroin
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents