Distress Tolerance and Buprenorphine (TRUST)

September 9, 2015 updated by: Michael Stein, MD, Butler Hospital

Distress Tolerance and Reducing Early Relapse in Buprenorphine Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Butler Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the Client Satisfaction Questionnaire-8
Time Frame: 4 months
assess patient satisfaction with services
4 months
buprenorphine treatment adherence
Time Frame: 4 months
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
Time Frame: 4 months
mechanisms hypothesized to mediate the relationship between DT treatment and improved buprenorphine outcomes will be assessed
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Butler Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

March 5, 2012

First Submitted That Met QC Criteria

March 14, 2012

First Posted (Estimate)

March 16, 2012

Study Record Updates

Last Update Posted (Estimate)

September 10, 2015

Last Update Submitted That Met QC Criteria

September 9, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA032767

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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