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

NCT ID: NCT00609089

Last Updated: 2012-08-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2013-06-30

Brief Summary

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.

Conditions

Heroin Dependence; Opiate Dependence; Substance Dependence

Keywords

Family; treatment; reinforcement; substance; trial; drug; abuse; HIV; risk

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

I

Community Reinforcement and Family Training for Retention in Treatment and Recovery and Reduction of HIV Risk Behavior (CRAFT-T)

Group Type: EXPERIMENTAL

CRAFT-T

Intervention Type: BEHAVIORAL

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).

II

Treatment As Usual

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: BEHAVIORAL

Treatment as usual will be the normal course of treatment for concerned significant others (CSOs) in the outpatient department.

Interventions

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).

Intervention Type: BEHAVIORAL

Treatment as usual

Treatment as usual will be the normal course of treatment for concerned significant others (CSOs) in the outpatient department.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Maryhaven

UNKNOWN

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Gregory S. Brigham

Clin Research Admin/Dir

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gregory S. Brigham, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

Maryhaven

Columbus, Ohio, United States

Countries

United States

References

Garner BR, Barnes B, Godley SH. MONITORING FIDELITY IN THE ADOLESCENT COMMUNITY REINFORCEMENT APPROACH (A-CRA): THE TRAINING PROCESS FOR A-CRA RATERS. J Behav Anal Health Sports Fit Med. 2009 Spring;2(1):43-54. doi: 10.1037/h0100373.

Reference Type: BACKGROUND

PMID: 21533009 (View on PubMed)

Other Identifiers

5K23DA021512-02

Identifier Type: NIH

Identifier Source: secondary_id

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5K23DA021512-02

Identifier Type: NIH

Identifier Source: org_study_id

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