Heroin DependencePhase 1/2NCT00609089
Community Reinforcement and Family Training for Drug Abuse Treatment Retention/HIV Risk Reduction
A Phase 1/2 study testing CRAFT-T and Treatment as usual in people with Heroin Dependence and Opiate Dependence, run by University of Cincinnati at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heroin Dependence, Opiate Dependence, Substance Dependence
- What is being tested?
- CRAFT-T and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jun 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Heroin Dependence, Opiate Dependence, Substance Dependence
- Being tested
- CRAFT-T, Treatment as usual
- Keywords
- Family, treatment, reinforcement, substance, trial, drug, abuse, HIV, risk
- Medical subject headings
- Heroin Dependence, Opioid-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRAFT-TBehavioural
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).
Treatment as usualBehavioural
Treatment as usual will be the normal course of treatment for concerned significant others (CSOs) in the outpatient department.
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Community Reinforcement and Family Training for Retention in Treatment and Recovery and Reduction of HIV Risk Behavior (CRAFT-T) Receives: Behavioral: CRAFT-T |
| II | Active comparator | Treatment As Usual Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is retention in drug abuse treatment, specifically time to first drop from services for at least 3 weeks duration.
Measured: 6 months
Secondary outcomes (15)
The Identified Patient's engagement in behaviors that increase the risk of contracting HIV, as measured by the RAB
Measured: 6 months
The concerned significant other's (CSO's) engagement in behaviors that increase the risk of contracting HIV, as measured by the RAB,
Measured: 6 months
The identified patient's successful completion of drug abuse treatment episode
Measured: 6 months
The portion of available treatment sessions attended during each assessment period including,
Measured: 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.
Measured: 6 months
The identified patient's substance use as reported by the CSO (collateral reports of drug use).
Measured: 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.
Measured: 6 months
Concerned significant other and identified patient's relationship satisfaction (the score on the General Happiness Scale of the RHS).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 6 months
Identified patient's use of professional services, other than substance abuse treatment, as reported on the TSR.
Measured: 6 months
Concerned significant others satisfaction with treatment as measured by the Participant Satisfaction Form.
Measured: 3 months
Identified patient's satisfaction with treatment as measured by the Participant Satisfaction
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2012
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heroin DependenceStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Maryhaven
- Responsible party
- Principal investigator, Gregory S. Brigham, University of Cincinnati
- Investigators
- Gregory S. Brigham, Ph.D., Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609089
- Sponsor's protocol ID
- 5K23DA021512-02
- Other IDs
- 5K23DA021512-02
- Status last verified
- Aug 2012
- First submitted
- 22 Jan 2008
- Last updated
- 14 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
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 at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stage 1 Study of Community Reinforcement and Family Training for Treatment Drug Abuse Treatment Retention/HIV Risk Reduction
- ClinicalTrials.gov ID
- NCT00609089
- Acronym / sponsor ID
- 5K23DA021512-02
- Conditions
- Heroin Dependence, Opiate Dependence, Substance Dependence
- Keywords
- Family, treatment, reinforcement, substance, trial, drug, abuse, HIV
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Maryhaven
- Study start
- Mar 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2013 (estimated)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Behavioral: CRAFT-TCommunity Reinforcement and Family Training for Retention in Treatment and Recovery and Reduction of HIV Risk Behavior (CRAFT-T) |
| II | Active comparator | Behavioral: Treatment as usualTreatment As Usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRAFT-TThe 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). | Behavioural | I |
| Treatment as usualTreatment as usual will be the normal course of treatment for concerned significant others (CSOs) in the outpatient department. | Behavioural | II |
Primary outcome
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
15 secondary outcomes
The Identified Patient's engagement in behaviors that increase the risk of contracting HIV, as measured by the RAB
Time frame: 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
The identified patient's successful completion of drug abuse treatment episode
Time frame: 6 months
The portion of available treatment sessions attended during each assessment period including,
Time frame: 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
The identified patient's substance use as reported by the CSO (collateral reports of drug use).
Time frame: 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
Concerned significant other and identified patient's relationship satisfaction (the score on the General Happiness Scale of the RHS).
Time frame: 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
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
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
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
Identified patient's use of professional services, other than substance abuse treatment, as reported on the TSR.
Time frame: 6 months
Concerned significant others satisfaction with treatment as measured by the Participant Satisfaction Form.
Time frame: 3 months
Identified patient's satisfaction with treatment as measured by the Participant Satisfaction
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2012.
- BackgroundBrigham, 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 .
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory S. Brigham, Ph.D. principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CRAFT-T and Treatment as usual in people with Heroin Dependence and Opiate Dependence, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00609089, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2012.