Drug Use Disorders Clinical Trial
Official title:
Increasing Treatment Adherence in Co-Occurring 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 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 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.
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