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Distress Tolerance and Buprenorphine (TRUST)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01556087
First Posted: March 16, 2012
Last Update Posted: September 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital
  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
Intervention Model: Parallel Assignment
Masking: Single (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 Michael Stein, MD, Butler Hospital:

Primary Outcome Measures:
  • the Client Satisfaction Questionnaire-8 [ Time Frame: 4 months ]
    assess patient satisfaction with services

  • buprenorphine treatment adherence [ Time Frame: 4 months ]
    adherence to buprenorphine treatment, which includes opioid use and risk behaviors, will be assessed


Secondary Outcome Measures:
  • distress tolerance persistence [ Time Frame: 4 months ]
    mechanisms hypothesized to mediate the relationship between DT treatment and improved buprenorphine outcomes will be assessed


Enrollment: 59
Study Start Date: March 2012
Study Completion Date: August 2015
Primary Completion Date: February 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556087


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

Responsible Party: Michael Stein, MD, Principal Investigator, Butler Hospital
ClinicalTrials.gov Identifier: NCT01556087     History of Changes
Other Study ID Numbers: DA032767
First Submitted: March 5, 2012
First Posted: March 16, 2012
Last Update Posted: September 10, 2015
Last Verified: September 2015

Keywords provided by Michael Stein, MD, Butler Hospital:
opioids
distress tolerance
buprenorphine

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