Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
59 participants
INTERVENTIONAL
2012-03-31
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Distress Tolerance
7 sessions aimed at increasing distress tolerance skills
Distress Tolerance
7 individual sessions aimed at increasing distress tolerance skills
Health Education
7 didactic health education sessions
Health Education
7 individual sessions with didactic health education information
Interventions
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Distress Tolerance
7 individual sessions aimed at increasing distress tolerance skills
Health Education
7 individual sessions with didactic health education information
Eligibility Criteria
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Inclusion Criteria
* plan to remain on buprenorphine for at least three months
* age between 18 and 65 years
* if female of childbearing potential -- must be using adequate contraception (an intrauterine device, oral contraceptive, depot contraceptive, a barrier method "every time," or hysterectomy) as assessed by the study physician
* has at least two persons they regularly contact and can provide contact information for them
* speaks English sufficiently to understand instructions and assessments.
Exclusion Criteria
* medically necessary prescription opioid treatment (e.g., for chronic pain)
* current criteria for a DSM-IV diagnosis of substance dependence for sedative/hypnotic drugs, alcohol, stimulants, cocaine, inhalants, hallucinogens
* a diagnosis of organic brain disorder, bipolar disorder, schizophrenia, schizo-affective, schizophreniform, or paranoid disorder, or major depression (subjects who meet criteria for "substance-induced mood disorder," or dysthymia only will not be excluded)
* current suicidality on the Modified Scale for Suicidal Ideation
* use of daily psychotropic, antidepressant, or anxiolytic medication
* evidence of neuropsychological dysfunction as assessed by the study physician with confirmation with the Folstein Mini-Mental Status Examination
* anticipated major painful event (significant surgical procedure) in the coming 6 months
* probation/parole requirements that might interfere with protocol participation
* history of allergic reaction to buprenorphine or naloxone.
18 Years
75 Years
ALL
No
Sponsors
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Butler Hospital
OTHER
Responsible Party
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Michael Stein, MD
Principal Investigator
Locations
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Butler Hospital
Providence, Rhode Island, United States
Countries
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Other Identifiers
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DA032767
Identifier Type: -
Identifier Source: org_study_id
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