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NCT00237822 · ClinicalTrials.gov registry record · Phase 2
Increasing Treatment Adherence in Co-Occurring Psychiatric and Drug Use Disorders
A Phase 2 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
NCT00237822 is a Phase 2 study that has completed, run by Yale University. The registered enrollment target is 75 participants.
The verdict
NCT00237822, a Phase 2 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
Study Summary
The investigators are proposing a study of treatment adherence in co-occurring psychiatric and drug use disorders (COD). The proposed study uses a 3-cell/condition design, within which 75 adult outpatients with co-occurring psychiatric disorders and drug abuse/dependence (CODDA) will be randomly assigned to one of the following brief, 8-week, manual-guided interventions following a 2-week "Assessment Only" baseline period: 1. Adherence Feedback (AF); this condition will entail weekly, 20-25 minute sessions of AF, which is a procedure that represents a technological advancement developed by Cramer et al. (1989, 1995, and 1999) and is based on the use of adherence data from the microelectronic monitor in Medication Event Monitoring System (MEMS) caps, 2. AF + Contingency Management (AF + CM); in this condition, participants will receive AF, as described above, PLUS contingency management. CM is based on the behavioral learning theory, which suggests that the occurrence of a behavior is increased as a function of the rate at which it is positively reinforced or rewarded, or 3. AF + Motivational Enhancement Therapy (AF + MET); in this condition, patients will receive AF, as described above, PLUS motivational enhancement therapy. MET is based on the idea that an effective way to motivate behavior change is to assist patients in clarifying their ambivalence (i.e., reasons for and against changing/adhering), utilizing a series of strategies based on client-centered psychotherapy, self-efficacy theory, and social psychology. The study will allow the evaluation of three hypotheses: 1. AF + MET is superior to AF + CM, 2. AF + MET is superior to AF alone, and 3. AF + CM is superior to AF alone. Primary outcome measures are: 1. rates of adherence to medication (i.e., selective serotonin reuptake inhibitors or SSRIs), as measured by MEMS caps and self-report, 2. rates of counseling attendance, and 3. reductions in illicit drug use, including achievement of abstinence, as as
Interventions
- BEHAVIORAL Adherence Feedback (AF)
- BEHAVIORAL AF + Contingency Management (AF + CM)
- BEHAVIORAL AF + Motivational Enhancement Therapy (AF + MET)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2003-09 |
| Est. Completion | 2007-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00237822
The ClinicalTrials.gov registry entry for NCT00237822 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Adherence Feedback (AF) is the first listed.
NCT00237822 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00237822 about?
NCT00237822 is a clinical study titled "Increasing Treatment Adherence in Co-Occurring Psychiatric and Drug Use Disorders". The investigators are proposing a study of treatment adherence in co-occurring psychiatric and drug use disorders (COD). The proposed study uses a 3-cell/condition design, within which 75 adult outpatients with co-occurring psychiatric disorders and drug abuse/dependence (CODDA) will be randomly ass...
What is the current status of trial NCT00237822?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2003-09. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00237822?
The interventions under investigation include: Adherence Feedback (AF) (BEHAVIORAL), AF + Contingency Management (AF + CM) (BEHAVIORAL), AF + Motivational Enhancement Therapy (AF + MET) (BEHAVIORAL).
Who is sponsoring clinical trial NCT00237822?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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