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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
What is being tested?
CRAFT-T and Treatment as usual
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.

United States1 site
  • Maryhaven

    Columbus, Ohio, 43207

Other trials in United States

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.

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 groups in NCT00609089
Study groupRoleWhat they receive
IExperimentalCommunity Reinforcement and Family Training for Retention in Treatment and Recovery and Reduction of HIV Risk Behavior (CRAFT-T)
Receives: Behavioral: CRAFT-T
IIActive comparatorTreatment As Usual
Receives: Behavioral: Treatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. The Identified Patient's engagement in behaviors that increase the risk of contracting HIV, as measured by the RAB

    Measured: 6 months

  2. 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

  3. The identified patient's successful completion of drug abuse treatment episode

    Measured: 6 months

  4. The portion of available treatment sessions attended during each assessment period including,

    Measured: 6 months

  5. 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

  6. The identified patient's substance use as reported by the CSO (collateral reports of drug use).

    Measured: 6 months

  7. 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

  8. Concerned significant other and identified patient's relationship satisfaction (the score on the General Happiness Scale of the RHS).

    Measured: 6 months

  9. 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

  10. 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

  11. 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

  12. 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

  13. Identified patient's use of professional services, other than substance abuse treatment, as reported on the TSR.

    Measured: 6 months

  14. Concerned significant others satisfaction with treatment as measured by the Participant Satisfaction Form.

    Measured: 3 months

  15. 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.

  1. First posted6 Feb 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionJun 2012
  4. Study completionJun 2013 (estimated)

Resources

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)
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 .

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.

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