NCT05787847

Brief Summary

The goal of this randomized control pilot study is to learn about a financial incentives intervention among individuals who use stimulants and take part in a community-based syringe exchange program. The main question it aims to answer is how financial incentives for not using stimulants will impact stimulant use. Participants in the experimental group will have the opportunity to earn financial incentives for providing a negative urine sample for stimulants using a point-of-care test, which indicates abstinence from stimulant use, along with health education on the health risks of stimulant use and substance injection. Researchers will compare the experimental group to the control group who will receive health education on the health risks of stimulants use and injection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

February 14, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 17, 2025

Completed
Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

March 15, 2023

Results QC Date

August 13, 2025

Last Update Submit

September 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Stimulant Free Urine Sample

    all samples will be assessed using point-of-care test urine drug test conducted at the center

    12 weeks

Study Arms (2)

Health Education

OTHER
Behavioral: Health Education

Health Education plus Incentives for Abstinence

EXPERIMENTAL
Behavioral: Incentives for AbstinenceBehavioral: Health Education

Interventions

Participants in the incentives for abstinence condition will have the opportunity to earn financial incentives for abstaining from stimulant use.

Health Education plus Incentives for Abstinence

The Health Education condition is based on a previous intervention used as a control in a number of other studies. Sessions consist of an educational program addressing a variety of health, wellness, and lifestyle topics adapted from a previously implemented wellness manual.

Health EducationHealth Education plus Incentives for Abstinence

Eligibility Criteria

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

You may qualify if:

  • be 18 years or older
  • report using stimulants in the past 30 days
  • meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis for stimulant use disorder at a moderate or severe level (i.e., 6 or more of the 11 criteria)
  • participation in services at syringe exchange program

You may not qualify if:

  • individuals who are cognitively impaired by their drug use or psychiatric conditions that could preclude informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Howard Center

Burlington, Vermont, 05401, United States

Location

Limitations and Caveats

This project was designed as a pilot study with a small sample size. As such, there are limitations of the statistical power due to the small sample size. Although the originally proposed sample size by condition was not met, the results are able to discern patterns of differences in the primary outcome by study condition.

Results Point of Contact

Title
Dr. Richard Rawson
Organization
University of Vermont

Publication Agreements

PI is Sponsor Employee
Yes

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
Research Professor

Study Record Dates

First Submitted

March 15, 2023

First Posted

March 28, 2023

Study Start

February 14, 2024

Primary Completion

July 30, 2024

Study Completion

July 30, 2024

Last Updated

September 17, 2025

Results First Posted

September 17, 2025

Record last verified: 2025-09

Locations