Cognitive behavioral therapy
Behavioral12 weekly sessions and 3 booster sessions of cognitive behavioral therapy
Other names: CBT
NCT Number: NCT00430482
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Bay Cove Treatment Center, Boston, Massachusetts, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
(2) Patients with a psychotic or organic mental disorder according to DSM-IV criteria.
(3) Patients receiving medication affecting methadone metabolism (e.g. rifampin).
(4) Patients with uncontrolled bipolar disorder as evidenced by meeting current criteria for mania or hypomania or meeting criteria for rapid cycling in the last year (as indicated by structured questioning of all patients meeting criteria for bipolar disorder).
(5) Patients unable to complete the informed consent or unable to understand study procedures in the informed consent process.
12 weekly sessions and 3 booster sessions of cognitive behavioral therapy
Other names: CBT
12 weekly sessions and 3 booster sessions of individual counseling
Other names: ICT
Time frame: Weekly assessments with summation over three time periods: baseline, treatment, and eight weeks of follow-up.
The primary outcome assessment for this study was the percentage of oral toxicology swabs that were positive of illicit substances. Participants completed these swabs at each assessment point, as well as at each study therapy session. Toxicology swabs were supervised by study staff and used oral specimen collection to screen for opiates, methadone, cocaine, benzodiazepines, amphetamines, THC, and barbiturates.
Time frame: Baseline, Mid Treatment, Treatment Endpoint, Follow-up Evaluation 1, Follow-up Evaluation 2
The composite score for drug use is determined by answers to 13 questions on the ASI: A/390 + B/390 + C/390 + D/390 + E/390 + F/390 + G/390 +H/390 + I/390 + J/390 + K/390 + L/52 + M/52. A single score is provided, with possible scores ranging from 0 to 1, with higher scores indicate greater drug use.
Boston University Charles River Campus
Other
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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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