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Distress Tolerance and Buprenorphine (TRUST)

Primary Purpose

Opioid Dependence

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Distress Tolerance

Health Education

About this trial

This is an interventional treatment trial for Opioid Dependence focused on measuring opioids, distress tolerance, buprenorphine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Butler Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Distress Tolerance

Health Education

Arm Description

7 sessions aimed at increasing distress tolerance skills

7 didactic health education sessions

Outcomes

Primary Outcome Measures

the Client Satisfaction Questionnaire-8

assess patient satisfaction with services

buprenorphine treatment adherence

adherence to buprenorphine treatment, which includes opioid use and risk behaviors, will be assessed

Secondary Outcome Measures

distress tolerance persistence

mechanisms hypothesized to mediate the relationship between DT treatment and improved buprenorphine outcomes will be assessed

Full Information

NCT ID

NCT01556087

First Posted

March 5, 2012

Last Updated

September 9, 2015

Sponsor

Butler Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01556087

Brief Title

Distress Tolerance and Buprenorphine

Acronym

TRUST

Official Title

Distress Tolerance and Reducing Early Relapse in Buprenorphine Patients

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Butler Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid Dependence

Keywords

opioids, distress tolerance, buprenorphine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Distress Tolerance

Arm Type

Experimental

Arm Description

7 sessions aimed at increasing distress tolerance skills

Arm Title

Health Education

Arm Type

Placebo Comparator

Arm Description

7 didactic health education sessions

Intervention Type

Behavioral

Intervention Name(s)

Distress Tolerance

Intervention Description

7 individual sessions aimed at increasing distress tolerance skills

Intervention Type

Behavioral

Intervention Name(s)

Health Education

Intervention Description

7 individual sessions with didactic health education information

Primary Outcome Measure Information:

Title

the Client Satisfaction Questionnaire-8

Description

assess patient satisfaction with services

Time Frame

4 months

Title

buprenorphine treatment adherence

Description

adherence to buprenorphine treatment, which includes opioid use and risk behaviors, will be assessed

Time Frame

4 months

Secondary Outcome Measure Information:

Title

distress tolerance persistence

Description

mechanisms hypothesized to mediate the relationship between DT treatment and improved buprenorphine outcomes will be assessed

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Butler Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02906

Country

United States

12. IPD Sharing Statement

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Distress Tolerance and Buprenorphine

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