Distress Tolerance and Buprenorphine

Phase 3

Completed

• Conditions: Opioid Dependence
• Interventions: Behavioral: Distress Tolerance; Behavioral: Health Education

• Registration Number: NCT01556087
• Lead Sponsor: Butler Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-05
• Study First Submitted QC: 2012-03-14
• Study First Posted: 2012-03-16
• Primary Completion: 2014-02
• Study Completion: 2015-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-09
• Last Update Posted: 2015-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Distress Tolerance	Distress Tolerance	7 sessions aimed at increasing distress tolerance skills
Health Education	Health Education	7 didactic health education sessions

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
distress tolerance persistence	4 months	mechanisms hypothesized to mediate the relationship between DT treatment and improved buprenorphine outcomes will be assessed

Trial Locations

Locations (1)

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States