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OpenTrials
Completed

NCT Number: NCT01556087

Distress Tolerance and Buprenorphine

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Distress Tolerance

Behavioral

7 individual sessions aimed at increasing distress tolerance skills

Health Education

Behavioral

7 individual sessions with didactic health education information

Primary outcomes

  1. the Client Satisfaction Questionnaire-8

    Time frame: 4 months

    assess patient satisfaction with services

  2. buprenorphine treatment adherence

    Time frame: 4 months

    adherence to buprenorphine treatment, which includes opioid use and risk behaviors, will be assessed

Secondary outcomes

  1. distress tolerance persistence

    Time frame: 4 months

    mechanisms hypothesized to mediate the relationship between DT treatment and improved buprenorphine outcomes will be assessed

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Registry information

Official study title

Distress Tolerance and Reducing Early Relapse in Buprenorphine Patients

Acronym: TRUST

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Mar 16, 2012
Registry last updated
Sep 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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