Official Title: “A Stage 1 Study of Community Reinforcement and Family Training for Treatment Drug Abuse Treatment Retention/HIV Risk Reduction”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Study Primary Completion Date: October 2011

Intervention(s) in this Clinical Trial

• Behavioral: CRAFT-TX
  • The Community Reinforcement and Family Training for Treatment Retention and HIV Risk Reduction treatment (CRAFT-TX) will be developed in phase 1 and 2 of the current study and is anticipated to consist of twelve manual-guided weekly one-hour individual sessions for the concerned significant other and 2 one hour sessions for the identified patient. The identified patient will receive this intervention in addition to the usual services at the drug treatment program (Maryhaven).
• Behavioral: Treatment as usual
  • Treatment as usual will be the normal course of treatment for concerned significant others (CSOs) in the outpatient department.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: I
  • CRAFT-TX
• Active Comparator: II
  • Treatment As Usual

Primary 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
    Safety Issue?: No

Secondary Measures

• The Identified Patient's engagement in behaviors that increase the risk of contracting HIV, as measured by the RAB
  • Time Frame: 6 months
    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
    Safety Issue?: No
• The identified patient's successful completion of drug abuse treatment episode
  • Time Frame: 6 months
    Safety Issue?: No
• The portion of available treatment sessions attended during each assessment period including,
  • Time Frame: 6 months
    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
    Safety Issue?: No
• The identified patient's substance use as reported by the CSO (collateral reports of drug use).
  • Time Frame: 6 months
    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
    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
    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
    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
    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
    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
    Safety Issue?: No
• Identified patient's use of professional services, other than substance abuse treatment, as reported on the TSR.
  • Time Frame: 6 months
    Safety Issue?: No
• Concerned significant others satisfaction with treatment as measured by the Participant Satisfaction Form.
  • Time Frame: 3 months
    Safety Issue?: No
• Identified patient's satisfaction with treatment as measured by the Participant Satisfaction
  • Time Frame: 1 month
    Safety Issue?: No

• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Gregory S. Brigham, Ph.D. Principal Investigator University of Cincinnati  

Overall Contact: Gregory S Brigham, Ph.D. 614-324-5417 Gbrigham@maryhaven.com

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00609089

Study ID Number: 5 K23 DA021512-02

ClinicalTrials.gov Identifier: NCT00609089

Health Authority: United States: Federal Government