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

NCT00237822 | Completed Phase 2

• 1 other identifier: K23DA015144
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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.
4. 4.AF + MET is superior to AF + CM,
5. 5.AF + MET is superior to AF alone, and
6. 6.AF + CM is superior to AF alone.
7. 7.rates of adherence to medication (i.e., selective serotonin reuptake inhibitors or SSRIs), as measured by MEMS caps and self-report,
8. 8.rates of counseling attendance, and
9. 9.reductions in illicit drug use, including achievement of abstinence, as assessed by twice-weekly urine toxicology tests and self-report.

Conditions

Diagnosis, Dual (Psychiatry); Psychiatric Diagnosis; Drug Use Disorders

Keywords

Treatment Adherence; Co-Occurring Disorders; Motivational Enhancement Therapy; Contingency Management; MEMS Caps

Outcome Measures

Primary Outcomes (1)

• Treatment adherence

Secondary Outcomes (2)

• Drug use

• Depression

Interventions

Adherence Feedback (AF) BEHAVIORAL

AF + Contingency Management (AF + CM) BEHAVIORAL

AF + Motivational Enhancement Therapy (AF + MET) BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Current major depressive episode
• Active suicidal/homicidal ideation/intent
• Current manic episode
• Visiting nurse or living in a facility that distributed medications

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Yale University Substance Abuse Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Disease; Mental Disorders; Substance-Related Disorders; Treatment Adherence and Compliance

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Michael V. Pantalon, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 7, 2005
• First Posted: October 12, 2005
• Study Start: September 1, 2003
• Study Completion: December 1, 2007
• Last Updated: October 17, 2017

Record last verified: 2005-10

Locations

US (1)