NCT01556087

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2012

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 16, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 10, 2015

Status Verified

September 1, 2015

Enrollment Period

1.9 years

First QC Date

March 5, 2012

Last Update Submit

September 9, 2015

Conditions

Opioid Dependence

Keywords

opioidsdistress tolerancebuprenorphine

Outcome Measures

Primary Outcomes (2)

  • the Client Satisfaction Questionnaire-8

    assess patient satisfaction with services

    4 months

  • buprenorphine treatment adherence

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

    4 months

Secondary Outcomes (1)

  • distress tolerance persistence

    4 months

Study Arms (2)

Distress Tolerance

EXPERIMENTAL

7 sessions aimed at increasing distress tolerance skills

Behavioral: Distress Tolerance

Health Education

PLACEBO COMPARATOR

7 didactic health education sessions

Behavioral: Health Education

Interventions

Distress ToleranceBEHAVIORAL

7 individual sessions aimed at increasing distress tolerance skills

Distress Tolerance
Health EducationBEHAVIORAL

7 individual sessions with didactic health education information

Health Education

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 5, 2012

First Posted

March 16, 2012

Study Start

March 1, 2012

Primary Completion

February 1, 2014

Study Completion

August 1, 2015

Last Updated

September 10, 2015

Record last verified: 2015-09

Locations

US(1)