NCT00809770

Brief Summary

The purpose of this study is to determine the effectiveness of a behavioral treatment, contingency management, in reducing stimulant use in persons with serious mental illness.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 17, 2008

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

4.3 years

First QC Date

December 15, 2008

Last Update Submit

November 7, 2016

Conditions

Drug AbuseSchizophreniaBipolar DisorderMajor Depressive Disorder

Keywords

stimulant abusedrug abuseschizophreniabipolar disordermajor depressive disordercontingency managementpsychosocial treatment

Outcome Measures

Primary Outcomes (1)

  • Stimulant drug use as measured by urine analysis

    Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month)

Secondary Outcomes (4)

  • Self report drug use

    Measured monthly througout the study

  • Other drug use as measured by urine analysis

    Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month)

  • Symptoms of mental illness

    Monthly throughout the study

  • Community outcomes (jail bookings, ER visits, mental health outcomes)

    The entire study period and three months prior and after study involvement

Study Arms (2)

1

EXPERIMENTAL

Contingency management

Behavioral: Contingency Management

2

OTHER

Non Contingent Control Condition

Behavioral: Non Contingent Control Condition

Interventions

Contingency ManagementBEHAVIORAL

Opportunities to earn rewards are given three times a week for 12 weeks contingent on negative urine analyses indicating drug abstinence

1
Non Contingent Control ConditionBEHAVIORAL

Opportunities to draw for rewards are provided three times a week for 12 weeks for providing urine analysis. Opportunities to earn rewards are not based on urine analysis results.

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Enrolled patient at Community Psychiatric Clinic (CPC), a large mental health center in urban Seattle, Washington;
  • Between 18 and 65 years of age;
  • Diagnosis of of methamphetamine, amphetamine(illegal), or cocaine dependence or abuse;
  • CPC medical record diagnosis of schizophrenia, schizoaffective disorder, bipolar I or II, or recurrent major depressive disorder
  • Stimulant drug use one month before enrollment;
  • Ability to understand written and spoken English;
  • CPC clinical case manager must affirm the potential participant's ability to provide informed consent and clinical appropriateness (i.e., safety/severity of mental/substance/ physical health) to participate in the study.

You may not qualify if:

  • Any medical/psychiatric condition, or severity of that condition, that, in the opinion of Dr. Ries, the PI, would compromise safe study participation
  • Chart defined organic brain disorder or dementia;
  • Current participation in a methadone maintenance program;
  • Any other circumstances that in the PI's opinion precludes safe study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (2)

  • Srebnik DS, McDonell MG, Ries RK, Andrus G. Conflicts among CMHC clinicians over the role of urine drug testing. Psychiatr Serv. 2014 May 1;65(5):700-1. doi: 10.1176/appi.ps.201300489. No abstract available.

    PMID: 24788740DERIVED

  • McDonell MG, Srebnik D, Angelo F, McPherson S, Lowe JM, Sugar A, Short RA, Roll JM, Ries RK. Randomized controlled trial of contingency management for stimulant use in community mental health patients with serious mental illness. Am J Psychiatry. 2013 Jan;170(1):94-101. doi: 10.1176/appi.ajp.2012.11121831.

    PMID: 23138961DERIVED

MeSH Terms

Conditions

Substance-Related DisordersSchizophreniaBipolar DisorderDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic DisordersBipolar and Related DisordersMood DisordersDepressive Disorder

Study Officials

  • Richard K Ries, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Division of Addiction

Study Record Dates

First Submitted

December 15, 2008

First Posted

December 17, 2008

Study Start

April 1, 2008

Primary Completion

July 1, 2012

Study Completion

August 1, 2013

Last Updated

November 8, 2016

Record last verified: 2016-11

Locations

US(1)