Distress Tolerance and Buprenorphine

Study Overview
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Brief Summary
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The investigators propose that inability to tolerate the distress of opioid withdrawal and the negative affect associated with early abstinence are key factors in early illicit opioid lapse and subsequent buprenorphine treatment drop-out. Our intervention aimed at increasing distress tolerance is designed to increase treatment adherence.

Official Title
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Distress Tolerance and Reducing Early Relapse in Buprenorphine Patients

Conditions
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Opioid Dependence

Intervention / Treatment
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* Behavioral: Distress Tolerance
* Behavioral: Health Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: initiating buprenorphine treatment (which requires meeting current criteria for a DSM-IV diagnosis of opioid dependence) 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: current methadone maintenance treatment program participation 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Distress Tolerance<br>7 sessions aimed at increasing distress tolerance skills | Behavioral: Distress Tolerance<br>* 7 individual sessions aimed at increasing distress tolerance skills<br>|
| Placebo Comparator: Health Education<br>7 didactic health education sessions | Behavioral: Health Education<br>* 7 individual sessions with didactic health education information<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Client Satisfaction Questionnaire-8 | assess patient satisfaction with services | 4 months | 
| buprenorphine treatment adherence | adherence to buprenorphine treatment, which includes opioid use and risk behaviors, will be assessed | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| distress tolerance persistence | mechanisms hypothesized to mediate the relationship between DT treatment and improved buprenorphine outcomes will be assessed | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioids, distress tolerance, buprenorphine