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View Clinical Trial (Medical Research Study)
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Community Reinforcement and Family Training for Drug Abuse Treatment Retention/HIV Risk Reduction - NCT00609089-43207 (Clinical Trial 201768)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy201768.aspx
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| City: |
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Columbus |
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State:
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OH |
| Zip Code: |
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43207 |
| Conditions: |
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Heroin Dependence - Opiate Dependence - Substance Dependence |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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. |
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| Study is available at: |
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Maryhaven
Columbus, OH 43207
United States
Primary Contact:
Gregory S Brigham, Ph.D.
Email: Gbrigham@maryhaven.com
Phone: 614-324-5417 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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August 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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