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

Drug Use Disorders Clinical Trial

Official title:

Increasing Treatment Adherence in Co-Occurring Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00237822
• Other study ID #: K23DA015144
• Secondary ID: K23DA015144
• Status: Completed
• Phase: Phase 2
• First received: October 7, 2005
• Last updated: October 13, 2017
• Start date: September 2003
• Est. completion date: December 2007

Study information

• Verified date: October 2005
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Diagnosis, Dual (Psychiatry)
• Disease
• Drug Use Disorders
• Mental Disorders
• Psychiatric Diagnosis
• Substance-Related Disorders

Intervention

Behavioral:
• Adherence Feedback (AF)

• AF + Contingency Management (AF + CM)

• AF + Motivational Enhancement Therapy (AF + MET)

Locations

Country	Name	City	State
United States	Yale University Substance Abuse Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment adherence
Secondary	Drug use
Secondary	Depression