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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05787847
Other study ID # UVermont - FI for StimUD
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 14, 2024
Est. completion date October 2024

Study information

Verified date May 2024
Source University of Vermont
Contact Richard Rawson
Phone 310-951-9091
Email richard.rawson@uvm.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The investigators are proposing a two condition, parallel groups, randomized control pilot study to evaluate the efficacy of a financial incentives intervention among individuals who use stimulants and take part in a community-based syringe exchange program. The study design will include recruiting service recipients who already participate in programs offered by a syringe exchange program.The experimental group will have the opportunity to earn financial incentives contingent on providing a negative urine sample for stimulants using a point-of-care test, which indicates abstinence from stimulant use, in addition to health education on the health risks of stimulant use and substance injection. The control group will receive health education on the health risks of stimulants use and injection. All participants will participate in their syringe exchange services as usual. The investigators chose the health education as the control because participants across both conditions already receive the services provided by the syringe exchange program. Moreover, this control condition will help control for a potential type of between-groups variability.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - failure to meet one or more inclusionary criteria - individuals who are cognitively impaired by their drug use or psychiatric conditions that could preclude informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Incentives for Abstinence
Participants in the incentives for abstinence condition will have the opportunity to earn financial incentives for abstaining from stimulant use.
Health Education
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.

Locations

Country Name City State
United States Howard Center Burlington Vermont

Sponsors (1)

Lead Sponsor Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary stimulant free urine sample all samples will be assessed using point-of-care test conducted at the center 12 weeks
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