NCT00237822

CompletedPhase 2

Increasing Treatment Adherence in Co-Occurring Psychiatric a...

Yale University Source

NCT00237822|CompletedPhase 2

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

Yale University ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

K23DA015144

NIH

Secondary identifiers

K23DA015144

NIH

Study Type

interventional

Estimated enrollment

75

Locations

1 country

Sites

1

Timeline

Study Start

September 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

December 2007

Actual (reported)

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 75 participants
Study completion date: December 2007
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 2003
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
October 7, 2005
Actual (reported)
First Posted
October 12, 2005
Actual (reported)
Study Completion
December 2007
Actual (reported)

Last Updated: October 17, 2017
Status Verified: October 2005
Last Update Submitted: October 13, 2017

Conditions

Diagnosis, Dual (Psychiatry)Drug Use Disorders Psychiatric Diagnosis

Keywords

Treatment AdherenceCo-Occurring DisordersMotivational Enhancement TherapyContingency ManagementMEMS 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

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

National Institute on Drug Abuse (NIDA)
NIHcollaborator
Yale University
Otherlead

Study Sites (1)

Yale University Substance Abuse Center

New Haven, Connecticut, 06519, United States

MeSH Terms

Conditions

DiseaseMental DisordersSubstance-Related DisordersTreatment Adherence and Compliance

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsChemically-Induced DisordersHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounseling

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 2003

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

December 2007

Actual (reported)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Contact the study team to confirm eligibility.

Mental Health Services

Behavioral Disciplines and Activities

Health Services

Health Care Facilities Workforce and Services

Last Updated

October 17, 2017

Record last verified: 2005-10

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00237822
Data provider: ClinicalTrials.gov
Source updated: 2017-10-17
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:21:26 UTC

Locations

US(1)

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

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations