Clinical Trials Directory

Trials / Completed

CompletedNCT00430482

Stress, Distress Intolerance, and Drug Dependence

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
133 (actual)
Sponsor
Boston University Charles River Campus · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

This study is designed to evaluate the relative efficacy of a novel treatment (CBT-IC) versus a standard individual drug-counseling treatment. The novel treatment emphasizes exposure to emotional cues for drug use as part of a comprehensive, yet brief, treatment strategy. These treatments are delivered to opiate-dependent, often poly-substance dependent, individuals in a comprehensive methadone maintenance program who have failed to respond adequately to current treatments.

Detailed description

This study study is designed to test further the efficacy of Cognitive-Behavior Therapy for Interoceptive Cues (CBT-IC - a treatment with a central focus on enhancing a patient's tolerance to the myriad forms of distress-sadness, boredom, anxiety, withdrawal sensations, etc.-that are linked to the stressful lives of drug-dependent individuals, and breaking the link between these emotional cues and drug-related attempts to avoid emotional distress) for intervening with chronically-stressed and treatment-resistant opiate-dependent outpatients. Features of this study of particular relevance to to RFA DA-04-001 include: (1) a focus on opiate-dependent patients undergoing chronic stress; (2) a model for the way in which chronic stress translates into chronic drug use; (2) a focus on the way in which stress-related symptoms serve as trigger for drug use; (3) a focus on both mediators and moderators of treatment that will inform treatment-matching efforts, including a focus on gender differences and emotional avoidance/distress intolerance; and (4) the examination of treatment outcome in a Stage II treatment trial.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCognitive Behavioral Therapy12 weekly sessions and 3 booster sessions of cognitive behavioral therapy
BEHAVIORALIndividual Counseling12 weekly sessions and 3 booster sessions of individual counseling

Timeline

Start date
2005-06-01
Primary completion
2011-07-01
Completion
2011-07-01
First posted
2007-02-02
Last updated
2019-07-10
Results posted
2019-07-10

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00430482. Inclusion in this directory is not an endorsement.