Distress Tolerance and Buprenorphine (TRUST)
This study is currently recruiting participants.
Verified April 2013 by Butler Hospital
Sponsor:
Butler Hospital
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital
ClinicalTrials.gov Identifier:
NCT01556087
First received: March 5, 2012
Last updated: April 17, 2013
Last verified: April 2013
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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: | December 2013 |
| Estimated Primary Completion Date: | September 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556087
Locations
| United States, Rhode Island | |
| Butler Hospital | Recruiting |
| Providence, Rhode Island, United States, 02906 | |
| Contact: Michael Stein, MD 401-455-6646 mstein@butler.org | |
| Principal Investigator: Michael Stein, MD | |
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: | April 17, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Butler Hospital:
|
opioids distress tolerance buprenorphine |
Additional relevant MeSH terms:
|
Opioid-Related Disorders Substance-Related Disorders Mental Disorders Buprenorphine Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotic Antagonists Narcotics |
ClinicalTrials.gov processed this record on May 16, 2013