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Drug AbuseNCT00809770

Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill

A study testing Contingency Management in people with Drug Abuse and Schizophrenia, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Drug Abuse, Schizophrenia, Bipolar Disorder
What is being tested?
Contingency Management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
1 siteUnited States
Study dates
Apr 2008to Aug 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Harborview Medical Center

    Seattle, Washington, 98104

Other trials in United States

About this study

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.

Read the detailed description

This study will evaluate the efficacy of a twelve week contingency management (CM) intervention for treating psycho-stimulant substance abuse when delivered in the context of a community mental health center (CMHC) setting for adults suffering from serious mental illness (SMI). The CM paradigm to be used is one which has been shown effective in several recent large clinical trials, using the variable magnitude of reinforcement procedure. The reinforcers will be vouchers or actual items useful for day to day living in this population. Two hundred SMI participants with co-occurring stimulant disorders will be recruited from a large urban CMHC and randomized to receive either the active CM paradigm plus treatment as usual (TAU), or TAU which will include the delivery of reinforcement for study involvement (reinforcement that is not contingent on drug abstinence). The primary outcome is change in psycho-stimulant use (methamphetamine, amphetamine and/or cocaine). Secondary outcomes include: changes in use of other illegal drugs or alcohol; changes in CMHC treatment adherence and follow-through; changes in psychiatric symptoms, quality of life, and community outcomes (homelessness, incarcerations, etc.). Additional outcomes to be measured include changes in drug craving, stage of change, nicotine use, and HIV risk status. The study involves two phases, the 12 week treatment phase, where CM and control treatments are delivered, as well as a 3 month follow up phase.

Being tested
Contingency Management, Non Contingent Control Condition
Keywords
stimulant abuse, drug abuse, schizophrenia, bipolar disorder, major depressive disorder, contingency management, psychosocial treatment
Medical subject headings
Substance-Related Disorders, Schizophrenia, Bipolar Disorder, Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Contingency ManagementBehavioural

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

  • Non Contingent Control ConditionBehavioural

    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.

Study groups in NCT00809770
Study groupRoleWhat they receive
1ExperimentalContingency management
Receives: Behavioral: Contingency Management
2OtherNon Contingent Control Condition
Receives: Behavioral: Non Contingent Control Condition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stimulant drug use as measured by urine analysis

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

Secondary outcomes (4)

  1. Self report drug use

    Measured: Measured monthly througout the study

  2. Other drug use as measured by urine analysis

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

  3. Symptoms of mental illness

    Measured: Monthly throughout the study

  4. Community outcomes (jail bookings, ER visits, mental health outcomes)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionJul 2012
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
176 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00809770
Sponsor's protocol ID
RDA022476A
Other IDs
R01DA022476, R01DA022476-01
Status last verified
Nov 2016
First submitted
15 Dec 2008
Last updated
8 Nov 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24788740

  • 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.

    PubMed 23138961

Questions about this trial

What is this clinical trial studying?

A study testing Contingency Management in people with Drug Abuse and Schizophrenia, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stimulant drug use as measured by urine analysis (time frame: Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00809770, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2016.

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