Distress Tolerance and Buprenorphine

Opioid Dependence Clinical Trial

— TRUST  

Official title:

Distress Tolerance and Reducing Early Relapse in Buprenorphine Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556087
• Other study ID #: DA032767
• Status: Completed
• Phase: Phase 3
• First received: March 5, 2012
• Last updated: September 9, 2015
• Start date: March 2012
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: August 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid Dependence

Intervention

Behavioral:
• Distress Tolerance
7 individual sessions aimed at increasing distress tolerance skills
• Health Education
7 individual sessions with didactic health education information

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Butler Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Client Satisfaction Questionnaire-8	assess patient satisfaction with services	4 months	No
Primary	buprenorphine treatment adherence	adherence to buprenorphine treatment, which includes opioid use and risk behaviors, will be assessed	4 months	No
Secondary	distress tolerance persistence	mechanisms hypothesized to mediate the relationship between DT treatment and improved buprenorphine outcomes will be assessed	4 months	No