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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Cognitive Behavioral Therapy | 12 weekly sessions and 3 booster sessions of cognitive behavioral therapy |
| BEHAVIORAL | Individual Counseling | 12 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.