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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Adherence Feedback (AF)
AF + Contingency Management (AF + CM)
AF + Motivational Enhancement Therapy (AF + MET)
Sponsored by
Yale University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Diagnosis, Dual (Psychiatry) focused on measuring Treatment Adherence, Co-Occurring Disorders, Motivational Enhancement Therapy, Contingency Management, MEMS Caps

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale University Substance Abuse Center

Outcomes

Primary Outcome Measures

Treatment adherence

Secondary Outcome Measures

Drug use
Depression

Full Information

First Posted
October 7, 2005
Last Updated
October 13, 2017
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00237822
Brief Title
Increasing Treatment Adherence in Co-Occurring Psychiatric and Drug Use Disorders
Official Title
Increasing Treatment Adherence in Co-Occurring Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
October 2005
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

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: 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, 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 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: AF + MET is superior to AF + CM, AF + MET is superior to AF alone, and AF + CM is superior to AF alone. Primary outcome measures are: rates of adherence to medication (i.e., selective serotonin reuptake inhibitors or SSRIs), as measured by MEMS caps and self-report, rates of counseling attendance, and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diagnosis, Dual (Psychiatry), Psychiatric Diagnosis, Drug Use Disorders
Keywords
Treatment Adherence, Co-Occurring Disorders, Motivational Enhancement Therapy, Contingency Management, MEMS Caps

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Adherence Feedback (AF)
Intervention Type
Behavioral
Intervention Name(s)
AF + Contingency Management (AF + CM)
Intervention Type
Behavioral
Intervention Name(s)
AF + Motivational Enhancement Therapy (AF + MET)
Primary Outcome Measure Information:
Title
Treatment adherence
Secondary Outcome Measure Information:
Title
Drug use
Title
Depression

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael V. Pantalon, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University Substance Abuse Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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