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Increasing Treatment Adherence in Co-Occurring Psychiatric and Drug Use Disorders

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00237822
First Posted: October 12, 2005
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
Yale University
  Purpose

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.


Condition Intervention 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
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Other
Official Title: Increasing Treatment Adherence in Co-Occurring Disorders

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Treatment adherence

Secondary Outcome Measures:
  • Drug use
  • Depression

Estimated Enrollment: 75
Study Start Date: September 2003
Study Completion Date: December 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently being treated with any class of psychotropic medication
  • Have used illicit drugs or abused prescription drugs within the past year
  • Are not adhering completely to their medication

Exclusion Criteria:

  • Current major depressive episode
  • Active suicidal/homicidal ideation/intent
  • Current manic episode
  • Visiting nurse or living in a facility that distributed medications
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Connecticut
Yale University Substance Abuse Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Michael V. Pantalon, Ph.D. Yale University
  More Information

ClinicalTrials.gov Identifier: NCT00237822     History of Changes
Other Study ID Numbers: K23DA015144 ( U.S. NIH Grant/Contract )
First Submitted: October 7, 2005
First Posted: October 12, 2005
Last Update Posted: October 17, 2017
Last Verified: October 2005

Keywords provided by Yale University:
Treatment Adherence
Co-Occurring Disorders
Motivational Enhancement Therapy
Contingency Management
MEMS Caps

Additional relevant MeSH terms:
Disease
Substance-Related Disorders
Mental Disorders
Pathologic Processes
Chemically-Induced Disorders