NCT05097547

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 28, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

October 28, 2021

Status Verified

October 1, 2021

Enrollment Period

6 months

First QC Date

October 1, 2021

Last Update Submit

October 15, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • stimulant abstinence

    Duration of stimulant abstinence based on urine drug screens

    12 weeks

Study Arms (1)

Contingency management

EXPERIMENTAL

This arm will include data from participants who received CM

Behavioral: Contingency Management

Interventions

Contingency management involves receiving monetary prizes in exchange for negative urine drug screens.

Contingency management

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Persons under the age of 18
  • Persons not able to attend follow-up clinic visits
  • Persons not able to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

Central Study Contacts

Nassima Ait-Daoud Tiouririne, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 1, 2021

First Posted

October 28, 2021

Study Start

October 1, 2021

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

October 28, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share