Distress Tolerance and Buprenorphine
Completed · Phase 3
Conditions studied: Opioid Dependence
In brief
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.
Key facts
- Study ID
- NCT01556087
- Run by
- Butler Hospital
- People needed
- 59
- Starts
- 2012-03-01
- Expected to finish
- 2015-08-01
- Last updated by the study team
- 2015-09-10
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Butler Hospital — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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