Distress Tolerance and Buprenorphine (TRUST)

Butler Hospital

Status and phase

Completed

Phase 3

Conditions

Opioid Dependence

Treatments

Behavioral: Distress Tolerance

Behavioral: Health Education

Study type

Interventional

Funder types

Other

Identifiers

NCT01556087

DA032767

Details and patient eligibility

About

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.

Enrollment

59 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.