Opioid Dependence
Conditions
Keywords
opioids, distress tolerance, buprenorphine
Brief 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.
Interventions
BEHAVIORALDistress Tolerance
7 individual sessions aimed at increasing distress tolerance skills
BEHAVIORALHealth Education
7 individual sessions with didactic health education information
Sponsors
Butler Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the Client Satisfaction Questionnaire-8 | 4 months | assess patient satisfaction with services |
| buprenorphine treatment adherence | 4 months | adherence to buprenorphine treatment, which includes opioid use and risk behaviors, will be assessed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| distress tolerance persistence | 4 months | mechanisms hypothesized to mediate the relationship between DT treatment and improved buprenorphine outcomes will be assessed |
Countries
United States
Outcome results
None listed