Community Reinforcement and Family Training for Drug Abuse Treatment Retention/HIV Risk Reduction

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Maryhaven
Information provided by (Responsible Party):
Gregory S. Brigham, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00609089
First received: January 22, 2008
Last updated: August 13, 2012
Last verified: August 2012
  Purpose

The planned research will adapt an intervention of known efficacy to target a new outcome of significant importance to public health. Specifically the Community Reinforcement and Family Training (CRAFT) procedures will be adapted, from reinforcing treatment entry, to reinforcing treatment retention and HIV risk behavior reduction in persons with opioid dependence who receive a Buprenorphine taper detoxification. The research plan includes three phases: 1) development of a manual guided therapy, 2) development of therapist training and fidelity measures and 3) a randomized pilot evaluation with 52 patients receiving either the new CRAFT treatment or treatment as usual.


Condition Intervention Phase
Heroin Dependence
Opiate Dependence
Substance Dependence
Behavioral: CRAFT-T
Behavioral: Treatment as usual
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Stage 1 Study of Community Reinforcement and Family Training for Treatment Drug Abuse Treatment Retention/HIV Risk Reduction

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • The primary outcome is retention in drug abuse treatment, specifically time to first drop from services for at least 3 weeks duration. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Identified Patient's engagement in behaviors that increase the risk of contracting HIV, as measured by the RAB [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The concerned significant other's (CSO's) engagement in behaviors that increase the risk of contracting HIV, as measured by the RAB, [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The identified patient's successful completion of drug abuse treatment episode [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The portion of available treatment sessions attended during each assessment period including, [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Substance use (defined as days of self-reported substance use, with partial confirmation by urinalysis and breathalyzer) during the active study phase and through the 3 month and 6-month follow-ups. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The identified patient's substance use as reported by the CSO (collateral reports of drug use). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Changes in concerned significant other and identified patient function as measured using the Brief Symptom Inventory. Specifically, the Global Severity Index (GSI) score. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Concerned significant other and identified patient's relationship satisfaction (the score on the General Happiness Scale of the RHS). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Marital satisfaction as measured by the KMS for the sub-sample of concerned significant others who are married to their identified patient's. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The identified patient's (IP) retention in any substance abuse specific intervention, including self-help, as reported by the IP on the Treatment tracking form. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The identified patient's retention in any substance abuse specific intervention, including self-help, as reported by CSO on the Treatment Tracking form. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Identified patient (IP) attendance at self-help groups (i.e., AA, NA, CA) (defined as the number of times that the IP has attended a self-help group as assessed on the Treatment Services Review). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Identified patient's use of professional services, other than substance abuse treatment, as reported on the TSR. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Concerned significant others satisfaction with treatment as measured by the Participant Satisfaction Form. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Identified patient's satisfaction with treatment as measured by the Participant Satisfaction [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 104
Study Start Date: March 2008
Estimated Study Completion Date: June 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
Community Reinforcement and Family Training for Retention in Treatment and Recovery and Reduction of HIV Risk Behavior (CRAFT-T)
Behavioral: CRAFT-T
The Community Reinforcement and Family Training for Treatment Retention and HIV Risk Reduction treatment (CRAFT-T) was be developed in phase 1 and 2 of the current study and consists of twelve manual-guided weekly one-hour individual sessions for the concerned significant other and 2 one hour sessions for the identified patient. The intervention also allows for up to two additional sessions (total of 14 visits) to help arrange re-entry into substance abuse treatment when needed. The identified patient receives this intervention in addition to the usual services at the drug treatment program (Maryhaven).
Active Comparator: II
Treatment As Usual
Behavioral: Treatment as usual
Treatment as usual will be the normal course of treatment for concerned significant others (CSOs) in the outpatient department.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Concerned Significant Other Inclusion Criteria: 1)be a first-degree relative, spouse, or intimate partner, or plan to live with the IP following the IP's detoxification, must plan to have contact with the IP at least 40% of the first 90 days post randomization, 2)be age 18 or older, 3)live within approximately 60 miles of Maryhaven, )be willing to participate in the protocol (i.e., to be randomized to treatment, to attend regular treatment sessions, to have their sessions audio taped, etc.), 5)be willing to sign a HIPAA-compliant release(s) of information to allow research staff access to any information collected from this subject during the study. Such staff may include RAs, therapists, supervisors, data managers, statisticians, QA personnel, etc., 6)be able to understand and provide written informed consent in English, 7)express desire to assist the IP with treatment retention and HIV risk behavior reduction.

Concerned Significant Other Exclusion Criteria: 1) are unlikely to be available to complete the entire protocol (e.g., plan to relocate, intention to not continue if assigned to a perceived unattractive arm of the study), 2)have a condition (e.g., medical complications, psychiatric problems, etc.) that would necessitate inpatient treatment or would make study participation difficult, 3)have engaged in domestic violence or assault within the previous year or have a history of severe violence (i.e., use of a weapon or violence leading to a hospitalization). For the purposes of the present protocol, domestic violence is defined as any physical abuse between intimately involved partners, roommates, or family members, 4)are currently at risk for suicide as evidenced by presence of at least one of the following; a) a history of a suicide attempt(s) and current suicidal ideation, b) current suicide ideation including recurrent thoughts of suicide with intention to harm themselves, c) persistent or recurring desire to die, d) a plan to harm themselves, e) indication that they would not take steps to save their own life, 5)have been the victim of severe domestic violence (i.e., use of a weapon or violence leading to a hospitalization) by the IP.

Identified Patient Inclusion Criteria: 1)be a first-degree relative, spouse, or intimate partner of the CSO, or someone who lives with the CSO, 2)be age 18 or older, 3)be currently enrolled in the BUP/NX 13-day taper protocol in Maryhaven's detoxification program, 4)intend to continue with outpatient treatment at Maryhaven, 5)be willing to participate in the protocol (i.e., to be randomized to treatment, to attend regular treatment sessions, to have their sessions audio taped, etc.), 6)be willing to sign a HIPAA compliant release(s) of information to allow research staff access to any information collected from this subject during the study. Such staff may include RAs, therapists, supervisors, data managers, statisticians, QA personnel, etc., 7)be able to understand and provide written informed consent in English, and 8)have a substance use disorder assessed by the Structured Clinical Interview for DSM-IV.

Identified Patient Exclusion Criteria: 1)have engaged in domestic violence or assault within the previous year or have a history of severe violence (i.e., use of a weapon or violence leading to a hospitalization), 2)have a history of a suicide attempt(s)within the past year or current suicidal ideation, 3)are currently at risk for suicide as evidenced by presence of at least one of the following; (same as CSO suicide lethality criteria above), 4)have a condition (e.g., medical complications, or psychiatric problems other than substance abuse, etc.) that would necessitate residential/inpatient treatment or would make study participation difficult, 5)under a court order to enter and remain in treatment program.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609089

Locations
United States, Ohio
Maryhaven
Columbus, Ohio, United States, 43207
Sponsors and Collaborators
University of Cincinnati
Maryhaven
Investigators
Principal Investigator: Gregory S. Brigham, Ph.D. University of Cincinnati
  More Information

No publications provided

Responsible Party: Gregory S. Brigham, Clin Research Admin/Dir, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00609089     History of Changes
Other Study ID Numbers: 5 K23 DA021512-02, 5K23DA021512-02
Study First Received: January 22, 2008
Last Updated: August 13, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Cincinnati:
Family
treatment
reinforcement
substance
trial
drug
abuse
HIV
risk

Additional relevant MeSH terms:
Substance-Related Disorders
Heroin Dependence
Opioid-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014