Increasing Treatment Adherence in Co-Occurring Psychiatric and Drug Use Disorders
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|ClinicalTrials.gov Identifier: NCT00237822|
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : October 17, 2017
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:
- 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,
- 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
- 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:
- AF + MET is superior to AF + CM,
- AF + MET is superior to AF alone, and
- AF + CM is superior to AF alone.
Primary outcome measures are:
- rates of adherence to medication (i.e., selective serotonin reuptake inhibitors or SSRIs), as measured by MEMS caps and self-report,
- rates of counseling attendance, and
- reductions in illicit drug use, including achievement of abstinence, as assessed by twice-weekly urine toxicology tests and self-report.
Secondary outcomes include reductions in psychiatric symptomatology and rates of re-hospitalization. The investigators will also evaluate the relationship between adherence and primary and secondary outcomes.
|Condition or disease||Intervention/treatment||Phase|
|Diagnosis, Dual (Psychiatry) Psychiatric Diagnosis Drug Use Disorders||Behavioral: Adherence Feedback (AF) Behavioral: AF + Contingency Management (AF + CM) Behavioral: AF + Motivational Enhancement Therapy (AF + MET)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Increasing Treatment Adherence in Co-Occurring Disorders|
|Study Start Date :||September 2003|
|Actual Study Completion Date :||December 2007|
- Treatment adherence
- Drug use
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00237822
|United States, Connecticut|
|Yale University Substance Abuse Center|
|New Haven, Connecticut, United States, 06519|
|Principal Investigator:||Michael V. Pantalon, Ph.D.||Yale University|