- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05097547
Contingency Management for Stimulant Use Disorders
October 15, 2021 updated by: Nassima Ait-Daoud Tiouririne, University of Virginia
The invetigators' objective is to implement Medication Assisted Treatment (MAT) and contingency management in patients affected by co-occurring opioid use disorder and stimulant use disorder.
Participants will continue to receive standard of care for their opioid use disorder via MAT at our Outpatient Based Opioid Treatment (OBOT) Clinic.
Participants' stimulant use disorder will be targeted through contingency management, with twice weekly urine drug screens and monetary prizes in exchange for negative urine drug screens.
Through regular clinic visits and the use of incentives, the investigators hope to increase treatment adherence and increase the number of negative urine drug screens in subjects struggling with co-morbid opioid use disorder and stimulant use disorder.
The investigators will determine whether or not this treatment is effective in this population, versus conventional treatment (baseline therapy patients were getting through OBOT).
The investigators' primary outcome measure will be stimulant abstinence duration during the twelve week study.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nassima Ait-Daoud Tiouririne, MD
- Phone Number: (434)243-0563
- Email: NAT7B@hscmail.mcc.virginia.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 and older
- Patients treated for opioid use disorder in the Outpatient Based Opioid Treatment (OBOT) Clinic and who also struggle with stimulant use disorder but failed conventional treatment (positive urine drug screen for substances other than THC and buprenorphine)
- Ideal candidates will test positive for 3 out of 4 weeks or more prior to starting contingency management
Exclusion Criteria:
- Persons under the age of 18
- Persons not able to attend follow-up clinic visits
- Persons not able to consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Contingency management
This arm will include data from participants who received CM
|
Contingency management involves receiving monetary prizes in exchange for negative urine drug screens.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
stimulant abstinence
Time Frame: 12 weeks
|
Duration of stimulant abstinence based on urine drug screens
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ginley MK, Pfund RA, Rash CJ, Zajac K. Long-term efficacy of contingency management treatment based on objective indicators of abstinence from illicit substance use up to 1 year following treatment: A meta-analysis. J Consult Clin Psychol. 2021 Jan;89(1):58-71. doi: 10.1037/ccp0000552.
- McPherson SM, Burduli E, Smith CL, Herron J, Oluwoye O, Hirchak K, Orr MF, McDonell MG, Roll JM. A review of contingency management for the treatment of substance-use disorders: adaptation for underserved populations, use of experimental technologies, and personalized optimization strategies. Subst Abuse Rehabil. 2018 Aug 13;9:43-57. doi: 10.2147/SAR.S138439. eCollection 2018.
- Miguel AQ, Madruga CS, Cogo-Moreira H, Yamauchi R, Simoes V, da Silva CJ, McPherson S, Roll JM, Laranjeira RR. Contingency management is effective in promoting abstinence and retention in treatment among crack cocaine users in Brazil: A randomized controlled trial. Psychol Addict Behav. 2016 Aug;30(5):536-543. doi: 10.1037/adb0000192. Epub 2016 Jul 21.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
October 1, 2021
Primary Completion (ANTICIPATED)
April 1, 2022
Study Completion (ANTICIPATED)
April 1, 2022
Study Registration Dates
First Submitted
October 1, 2021
First Submitted That Met QC Criteria
October 15, 2021
First Posted (ACTUAL)
October 28, 2021
Study Record Updates
Last Update Posted (ACTUAL)
October 28, 2021
Last Update Submitted That Met QC Criteria
October 15, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- HSR210335
- 17803 (OTHER: HSR Submission Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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