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

Primary Purpose

Heroin Dependence, Opiate Dependence, Substance Dependence

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CRAFT-T
Treatment as usual
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heroin Dependence focused on measuring Family, treatment, reinforcement, substance, trial, drug, abuse, HIV, risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Maryhaven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

I

II

Arm Description

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

Treatment As Usual

Outcomes

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.

Secondary Outcome Measures

The Identified Patient's engagement in behaviors that increase the risk of contracting HIV, as measured by the RAB
The concerned significant other's (CSO's) engagement in behaviors that increase the risk of contracting HIV, as measured by the RAB,
The identified patient's successful completion of drug abuse treatment episode
The portion of available treatment sessions attended during each assessment period including,
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.
The identified patient's substance use as reported by the CSO (collateral reports of drug use).
Changes in concerned significant other and identified patient function as measured using the Brief Symptom Inventory. Specifically, the Global Severity Index (GSI) score.
Concerned significant other and identified patient's relationship satisfaction (the score on the General Happiness Scale of the RHS).
Marital satisfaction as measured by the KMS for the sub-sample of concerned significant others who are married to their identified patient's.
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.
The identified patient's retention in any substance abuse specific intervention, including self-help, as reported by CSO on the Treatment Tracking form.
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).
Identified patient's use of professional services, other than substance abuse treatment, as reported on the TSR.
Concerned significant others satisfaction with treatment as measured by the Participant Satisfaction Form.
Identified patient's satisfaction with treatment as measured by the Participant Satisfaction

Full Information

First Posted
January 22, 2008
Last Updated
August 13, 2012
Sponsor
University of Cincinnati
Collaborators
National Institute on Drug Abuse (NIDA), Maryhaven
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1. Study Identification

Unique Protocol Identification Number
NCT00609089
Brief Title
Community Reinforcement and Family Training for Drug Abuse Treatment Retention/HIV Risk Reduction
Official Title
A Stage 1 Study of Community Reinforcement and Family Training for Treatment Drug Abuse Treatment Retention/HIV Risk Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
National Institute on Drug Abuse (NIDA), Maryhaven

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heroin Dependence, Opiate Dependence, Substance Dependence
Keywords
Family, treatment, reinforcement, substance, trial, drug, abuse, HIV, risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm Description
Community Reinforcement and Family Training for Retention in Treatment and Recovery and Reduction of HIV Risk Behavior (CRAFT-T)
Arm Title
II
Arm Type
Active Comparator
Arm Description
Treatment As Usual
Intervention Type
Behavioral
Intervention Name(s)
CRAFT-T
Intervention Description
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
Intervention Name(s)
Treatment as usual
Intervention Description
Treatment as usual will be the normal course of treatment for concerned significant others (CSOs) in the outpatient department.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
The Identified Patient's engagement in behaviors that increase the risk of contracting HIV, as measured by the RAB
Time Frame
6 months
Title
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
Title
The identified patient's successful completion of drug abuse treatment episode
Time Frame
6 months
Title
The portion of available treatment sessions attended during each assessment period including,
Time Frame
6 months
Title
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
Title
The identified patient's substance use as reported by the CSO (collateral reports of drug use).
Time Frame
6 months
Title
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
Title
Concerned significant other and identified patient's relationship satisfaction (the score on the General Happiness Scale of the RHS).
Time Frame
6 months
Title
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
Title
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
Title
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
Title
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
Title
Identified patient's use of professional services, other than substance abuse treatment, as reported on the TSR.
Time Frame
6 months
Title
Concerned significant others satisfaction with treatment as measured by the Participant Satisfaction Form.
Time Frame
3 months
Title
Identified patient's satisfaction with treatment as measured by the Participant Satisfaction
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory S. Brigham, Ph.D.
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maryhaven
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43207
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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 .
Results Reference
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Community Reinforcement and Family Training for Drug Abuse Treatment Retention/HIV Risk Reduction

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