Stimulant UseNCT05097547
Contingency Management for Stimulant Use Disorders
A study testing Contingency Management in people with Stimulant Use and Contingency Management, run by University of Virginia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stimulant Use, Contingency Management
- What is being tested?
- Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Apr 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Persons under the age of 18
- Persons not able to attend follow-up clinic visits
- Persons not able to consent
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Stimulant Use, Contingency Management
- Being tested
- Contingency Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency ManagementBehavioural
Contingency management involves receiving monetary prizes in exchange for negative urine drug screens.
| Study group | Role | What they receive |
|---|---|---|
| Contingency management | Experimental | This arm will include data from participants who received CM Receives: Behavioral: Contingency Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
stimulant abstinence
Duration of stimulant abstinence based on urine drug screens
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study startOct 2021 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stimulant UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nassima Ait-Daoud Tiouririne, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097547
- Sponsor's protocol ID
- HSR210335
- Other IDs
- 17803
- Status last verified
- Oct 2021
- First submitted
- 1 Oct 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33507776McPherson 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.
PubMed 30147392Miguel 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.
PubMed 27442691
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contingency Management for Stimulant Use Disorders
- ClinicalTrials.gov ID
- NCT05097547
- Acronym / sponsor ID
- HSR210335
- Conditions
- Stimulant Use, Contingency Management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 28 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contingency management | Experimental | Behavioral: Contingency ManagementThis arm will include data from participants who received CM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Persons under the age of 18
- Persons not able to attend follow-up clinic visits
- Persons not able to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contingency ManagementContingency management involves receiving monetary prizes in exchange for negative urine drug screens. | Behavioural | Contingency management |
Primary outcome
stimulant abstinence
Time frame: 12 weeks
Duration of stimulant abstinence based on urine drug screens
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Results publication: PubMed 33507776Ginley 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.
- Results publication: PubMed 30147392McPherson 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.
- Results publication: PubMed 27442691Miguel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management in people with Stimulant Use and Contingency Management, run by University of Virginia.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nassima Ait-Daoud Tiouririne, MD ((434)243-0563, NAT7B@hscmail.mcc.virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stimulant abstinence (time frame: 12 weeks). 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 NCT05097547, which also lists 3 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 28 Oct 2021.