Increasing Treatment Adherence in Co-Occurring Psychiatric and Drug Use Disorders
NCT ID: NCT00237822
Last Updated: 2017-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
75 participants
INTERVENTIONAL
2003-09-30
2007-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Interventions
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Adherence Feedback (AF)
AF + Contingency Management (AF + CM)
AF + Motivational Enhancement Therapy (AF + MET)
Eligibility Criteria
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Inclusion Criteria
* Have used illicit drugs or abused prescription drugs within the past year
* Are not adhering completely to their medication
Exclusion Criteria
* Active suicidal/homicidal ideation/intent
* Current manic episode
* Visiting nurse or living in a facility that distributed medications
18 Years
85 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Yale University
OTHER
Principal Investigators
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Michael V. Pantalon, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale University Substance Abuse Center
New Haven, Connecticut, United States
Countries
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