Distress Tolerance and Buprenorphine (TRUST)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital
ClinicalTrials.gov Identifier:
NCT01556087
First received: March 5, 2012
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Opioid Dependence
Behavioral: Distress Tolerance
Behavioral: Health Education
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Distress Tolerance and Reducing Early Relapse in Buprenorphine Patients

Resource links provided by NLM:


Further study details as provided by Butler Hospital:

Primary Outcome Measures:
  • the Client Satisfaction Questionnaire-8 [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    assess patient satisfaction with services

  • buprenorphine treatment adherence [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    adherence to buprenorphine treatment, which includes opioid use and risk behaviors, will be assessed


Secondary Outcome Measures:
  • distress tolerance persistence [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    mechanisms hypothesized to mediate the relationship between DT treatment and improved buprenorphine outcomes will be assessed


Estimated Enrollment: 60
Study Start Date: March 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556087

Locations
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
  More Information

No publications provided

Responsible Party: Michael Stein, MD, Principal Investigator, Butler Hospital
ClinicalTrials.gov Identifier: NCT01556087     History of Changes
Other Study ID Numbers: DA032767
Study First Received: March 5, 2012
Last Updated: July 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Butler Hospital:
opioids
distress tolerance
buprenorphine

Additional relevant MeSH terms:
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists

ClinicalTrials.gov processed this record on September 18, 2014