- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00609089
Community Reinforcement and Family Training for Drug Abuse Treatment Retention/HIV Risk Reduction
A Stage 1 Study of Community Reinforcement and Family Training for Treatment Drug Abuse Treatment Retention/HIV Risk Reduction
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43207
- Maryhaven
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: I
Community Reinforcement and Family Training for Retention in Treatment and Recovery and Reduction of HIV Risk Behavior (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
|
Treatment as usual will be the normal course of treatment for concerned significant others (CSOs) in the outpatient department.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The Identified Patient's engagement in behaviors that increase the risk of contracting HIV, as measured by the RAB
Time Frame: 6 months
|
6 months
|
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
|
6 months
|
The identified patient's successful completion of drug abuse treatment episode
Time Frame: 6 months
|
6 months
|
The portion of available treatment sessions attended during each assessment period including,
Time Frame: 6 months
|
6 months
|
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
|
6 months
|
The identified patient's substance use as reported by the CSO (collateral reports of drug use).
Time Frame: 6 months
|
6 months
|
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
|
6 months
|
Concerned significant other and identified patient's relationship satisfaction (the score on the General Happiness Scale of the RHS).
Time Frame: 6 months
|
6 months
|
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
|
6 months
|
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
|
6 months
|
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
|
6 months
|
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
|
6 months
|
Identified patient's use of professional services, other than substance abuse treatment, as reported on the TSR.
Time Frame: 6 months
|
6 months
|
Concerned significant others satisfaction with treatment as measured by the Participant Satisfaction Form.
Time Frame: 3 months
|
3 months
|
Identified patient's satisfaction with treatment as measured by the Participant Satisfaction
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gregory S. Brigham, Ph.D., University of Cincinnati
Publications and helpful links
General Publications
- Brigham, GS, Slesnick, N., Somoza, E., Horn, P., and Rich, J., (2009). Community Reinforcement and Family Training for Treatment Retention and HIV Behavioral Risk Reduction: A Study Protocol. Journal of Behavior Analysis in Health, Sports, Fitness, and Medicine, 2(1), 91-108. http://www.baojournal.com/Health%20Journal/JBAHSFM-2-1.pdf .
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5K23DA021512-02 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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