Skip to main content
OpenTrials
Completed

NCT Number: NCT00237822

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 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale University Substance Abuse Center

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adherence Feedback (AF)

Behavioral

AF + Contingency Management (AF + CM)

Behavioral

AF + Motivational Enhancement Therapy (AF + MET)

Behavioral

Primary outcomes

  1. Treatment adherence

Secondary outcomes

  1. Drug use

  2. Depression

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Increasing Treatment Adherence in Co-Occurring Disorders

Important dates

Study start
2003
Study completion
2007
First posted
Oct 12, 2005
Registry last updated
Oct 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.