Motivational Interviewing to Increase Uptake of Drug Checking and Safe Drug Use Behaviors to Reduce Overdose

NCT06855836 | Active Not Recruiting DMC

• 1 other identifier: 1R33DA061260-01
• Study Type: interventional
• Target: 588
• Locations: 1 country
• Sites: 1

Brief Summary

A hybrid type 1 study will be conducted to evaluate efficacy and preliminary implementation considerations for a novel intervention to promote uptake of drug checking services (DCS) and safer drug use behaviors among people who use drugs (PWUD) to reduce incidence of overdose (OD) and HIV and Hepatitis C virus (HCV) infections in San Diego County. Along with \~50 other syringe services programs (SSPs) in the US, the Harm Reduction Coalition San Diego (HRCSD), a local SSP, recently launched CheckSD (San Diego), a DCS using test strips (TS) and Fourier Transform Infrared Spectrometry (FTIR) that allows people to submit drug samples with non-nominal identifiers and obtain personalized results. While most existing DCS using FTIR offer some counseling, no theory-based interventions to increase DCS uptake and promote post-DCS adoption of safer drug use behaviors have been rigorously evaluated

Conditions

Overdose

Outcome Measures

Primary Outcomes (1)

• Risk rates of fatal and non-fatal overdose over 30 months

  Rate of fatal and non-fatal ODs over the course of the study (i.e., the total # of ODs that a participant experiences during the study offset by the natural log of the time spent at risk during the study). Self-reported and obtained through record linkage between MI-CHANCE and emergency medical services and the medical examiner's office to obtain data on ODs that received medical attention and OD deaths, respectively

  Through study completion, an average of 30 months

Secondary Outcomes (2)

• Frequency of drug checking service utilization

  At baseline and every 6 months for 30 months

• Risk rates of HIV/HCV infection over 30 months

  Through study completion, an average of 30 months

Study Arms (2)

Standard of Care Control (SOC; Group 1) -TS + FTIR + Flu and Hepatitis A education.

PLACEBO COMPARATOR

Participants will receive naloxone, overdose prevention pamphlets and be shown videos (English or Spanish) on how naloxone works. Participants will be offered the services of drug sample testing by CheckSD's technician after their study session. The training videos will be on Flu and Hepatitis A education. Overall, the session for Group 1 as the attention control participants will last 30 minutes.

Behavioral: TS + FTIR + Flu and Hepatitis A Education

MI-CHANCE Intervention (Group 2) - TS+FTIR+MI.

EXPERIMENTAL

Participants will receive naloxone, overdose prevention pamphlets and MI in a 30-minute counseling session. Trained peer-support specialists will engage participants in discussion on the drug supply, ask to rate how certain they are about their drugs' content, how they perceive their OD risk, and shown a brief video about FTIR. Using "decisional balance", participants will identify pros and cons of regularly using DCS prior to drug use and modifying drug use behaviors based on their own potential safer alternatives. Once the balance shifts towards positive change, they will be offered to get their own drug tested by CheckSD's technician and provided with results highlighting drug potency and purity. If they decline, a dummy sample containing fentanyl will be used. Participants will develop an action plan with harm reduction principles to problem-solve specific challenges, identify their goals to use DCS and prevent OD.

Behavioral: MI-CHANCE (TS + FTIR + MI)

Interventions

MI-CHANCE (TS + FTIR + MI) BEHAVIORAL

MI-CHANCE was built following key principles of MI (partnership, acceptance, compassion and evocation) to empower PWUD, help them identify potential benefits of DCS and strategies to integrate these into their daily lives. The manual follows three key stages: 1) introducing DCS, 2) generating change talk, and 3) verbalizing commitment, using open questions, affirmations, reflections and summaries. Pros and cons for regularly using CheckSD and changing drug use behaviors accordingly were identified in the literature and through discussions with PWUD and HRCSD staff. Peer support specialists are urged to mirror participants' own language (e.g., oxy or M30s=oxycontin; carga= heroin; malilla=withdrawal, fetty=fentanyl). Challenges were categorized into 8 key areas: legal, financial, scheduling, transportation, ability to change drug use behaviors, communication with SSP staff, managing mood and substance use.

Also known as: Motivational Interviewing

MI-CHANCE Intervention (Group 2) - TS+FTIR+MI.

TS + FTIR + Flu and Hepatitis A Education BEHAVIORAL

Naloxone and educational materials (i.e. pamphlets) on overdose prevention, videos (English or Spanish) on naloxone, flu and Hepatitis A education.

Standard of Care Control (SOC; Group 1) -TS + FTIR + Flu and Hepatitis A education.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A total of 588 PWUD participants will be recruited for the proposed study (MI-CHANCE). To be eligible to participate in this study, an individual must meet all of the following criteria:
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Be aged ≥18 years at time of recruitment
• Must have used illicit opiates (e.g., heroin, fentanyl) and/or methamphetamine ≤1 week prior to recruitment date
• Live in San Diego County with no plans to permanently move over the next 30 months
• Have not previously used the CheckSD drug checking service
• Enrolled into ongoing prospective cohort study La Frontera (the border) (existing or new participants)
• Enrollment will be capped so that \<25% of the sample reports only using methamphetamine to ensure that the sample is comprised primarily of people who use opiates who are at greatest risk of OD. Recruitment will be done through targeted sampling at hotspots as well as homeless encampments, shelters and outreach through social media.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Not being able to provide a signed and dated informed consent form
• Not willing to comply with all study procedures and availability for the duration of the study
• Currently enrolled in another randomized controlled trial
• Not having used illicit opiates (e.g., heroin, fentanyl), methamphetamine ≤1 week prior to recruitment date
• Having used CheckSD (i.e. drug testing with TS+FTIR)
• Participated in the MI-CHANCE pilot

Sponsors & Collaborators

• University of California, San Diego: lead
• Harm Reduction Coalition of San Diego (HRCSD): collaborator

Study Sites (1)

MI CHANCE - Park Blvd

San Diego, California, 92103, United States

Location

Related Publications (24)

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  PMID: 41029610 DERIVED

MeSH Terms

Conditions

Drug Overdose

Interventions

Spectroscopy, Fourier Transform Infrared; Motivational Interviewing; Influenza Vaccines

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spectrophotometry, Infrared; Spectrophotometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Spectrum Analysis; Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Harold Simon Distinguished Professor, Co-director, Center for Innovative Phage Applications & Therapeutics (IPATH) Division of Infectious Diseases and Global Public Health Department of Medicine, UC San Diego Health Sciences

Model Details: All recruited study participants will receive the Overdose Education and Naloxone Distribution (OEND) materials. The control group will receive additional Flu and Hepatitis A education as Group 1, and the experimental group will receive the MI-CHANCE intervention as Group 2

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 4, 2025
• Study Start: March 3, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

US (1)