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OverdoseMI-CHANCENCT06855836

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

A study testing MI-CHANCE (TS + FTIR + MI) and TS + FTIR + Flu and Hepatitis A Education in people with Overdose, run by University of California, San Diego at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Overdose
What is being tested?
MI-CHANCE (TS + FTIR + MI) and TS + FTIR + Flu and Hepatitis A Education
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
588 participants
Where
1 siteUnited States
Study dates
3 Mar 2025to May 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Have not previously used the FTIR drug checking service
  • Enrolled into ongoing prospective cohort study La Frontera (the border) (existing or new participants)
  • Enrollment will be capped so that <50% 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • MI CHANCE - Park Blvd

    San Diego, California, 92103

Other trials in United States

About this study

Official title: Efficacy and Implementation Considerations for a Peer-led Motivational Interviewing Intervention to Promote Uptake of Drug Checking Services and Safe Drug Use Behaviors to Reduce Overdose

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.

Approximately 50 syringe services programs (SSPs) in the US now offer advanced drug checking services using test strips (TS) and Fourier Transform Infrared Spectrometry (FTIR), allowing people to submit drug samples with non-nominal identifiers and obtain personalized results. While most existing FTIRs offer some counseling, no theory-based interventions to increase FTIR uptake and promote post-FTIR adoption of safer drug use behaviors have been rigorously evaluated.

Read the detailed description

588 PWUD who have not yet used FTIR will be recruited into a two-arm randomized controlled trial (RCT) (N=294 per group). Recruitment sources will be the community and La Frontera study. Both arms will have access to FTIR's standard of care (SOC) already available at SSP sites (i.e., FTIR, and overdose education and naloxone distribution (OEND)). PWUD randomized to receive MI-CHANCE will receive it from peer support specialists who will be trained in motivational interviewing (MI) to encourage FTIR uptake and safer drug use behaviors. Those in the attention-control SOC arm will receive Flu and Hepatitis A education. All will undergo semi-annual follow-up for 30 months.

Primary Objective: To test the efficacy of MI-CHANCE on reducing rates of combined fatal and non-fatal OD over 30 months and examine social cognitive theory (SCT)-informed mediators and moderators of intervention effects (i.e., knowledge, outcome expectancies, self-efficacy)

Conditions
Overdose
Being tested
MI-CHANCE (TS + FTIR + MI), TS + FTIR + Flu and Hepatitis A Education
Medical subject headings
Drug Overdose

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MI-CHANCE (TS + FTIR + MI)Behavioural

    Also called Motivational Interviewing

    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 FTIR and changing drug use behaviors accordingly were identified in the literature and through discussions with PWUD and peer support specialists. 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.

  • TS + FTIR + Flu and Hepatitis A EducationBehavioural

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

Study groups in NCT06855836
Study groupRoleWhat they receive
Standard of Care Control (SOC; Group 1) -TS + FTIR + Flu and Hepatitis A education.Placebo comparatorParticipants 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 the FTIR 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.
Receives: Behavioral: TS + FTIR + Flu and Hepatitis A Education
MI-CHANCE Intervention (Group 2) - TS+FTIR+MI.ExperimentalParticipants 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 FTIR 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 the FTIR 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 FTIR and prevent OD.
Receives: Behavioral: MI-CHANCE (TS + FTIR + MI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Through study completion, an average of 30 months

Secondary outcomes (2)
  1. Frequency of drug checking service utilization

    Number of times one utilized FTIR over the past 6 months. Self-reported

    Measured: At baseline and every 6 months for 30 months

  2. Risk rates of HIV/HCV infection over 30 months

    Rates of HIV and HCV infection determined through serology (biological sample collection) over the course of the study (i.e. between baseline and 30 months)

    Measured: Through study completion, an average of 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2025
  2. Study start3 Mar 2025
  3. Primary completionFeb 2029 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
None (open label)
Enrolment
588 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06855836
Sponsor's protocol ID
1R33DA061260-01
Acronym
MI-CHANCE
Status last verified
Mar 2026
First submitted
25 Feb 2025
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Geldhof, G. J., Anthony, K. P., Selig, J. P., & Mendez-Luck, C. A. (2018). Accommodating binary and count variables in mediation: A case for conditional indirect effects. International Journal of Behavioral Development, 42(2), 300-308. https://doi.org/10.1177/0165025417727876

  • Friedman J, Godvin M, Molina C, Romero R, Borquez A, Avra T, Goodman-Meza D, Strathdee S, Bourgois P, Shover CL. Fentanyl, heroin, and methamphetamine-based counterfeit pills sold at tourist-oriented pharmacies in Mexico: An ethnographic and drug checking study. Drug Alcohol Depend. 2023 Aug 1;249:110819. doi: 10.1016/j.drugalcdep.2023.110819. Epub 2023 Jun 9.

    PubMed 37348270
  • Alexander RS, Canver BR, Sue KL, Morford KL. Xylazine and Overdoses: Trends, Concerns, and Recommendations. Am J Public Health. 2022 Aug;112(8):1212-1216. doi: 10.2105/AJPH.2022.306881.

    PubMed 35830662
  • Friedman J, Montero F, Bourgois P, Wahbi R, Dye D, Goodman-Meza D, Shover C. Xylazine spreads across the US: A growing component of the increasingly synthetic and polysubstance overdose crisis. Drug Alcohol Depend. 2022 Apr 1;233:109380. doi: 10.1016/j.drugalcdep.2022.109380. Epub 2022 Feb 26.

    PubMed 35247724
  • Roberts A, Korona-Bailey J, Mukhopadhyay S. Notes from the Field: Nitazene-Related Deaths - Tennessee, 2019-2021. MMWR Morb Mortal Wkly Rep. 2022 Sep 16;71(37):1196-1197. doi: 10.15585/mmwr.mm7137a5. No abstract available.

    PubMed 36107790
  • Riggins A. Dangerous mix of fentanyl and animal tranquilizer detected in few seizures in San Diego. San Diego Union Tribune, January 16, 2023

  • Riggins A. San Diego man sentenced in fentanyl-xylazine case as local evidence of dangerous 'tranq' drug grows. San Diego Union Tribune, September 9, 2023.

  • Volkow ND, Califf RM, Sokolowska M, Tabak LA, Compton WM. Testing for Fentanyl - Urgent Need for Practice-Relevant and Public Health Research. N Engl J Med. 2023 Jun 15;388(24):2214-2217. doi: 10.1056/NEJMp2302857. Epub 2023 Jun 10. No abstract available.

    PubMed 37306505
  • California Health and Safety Code. Division 10. Uniform controlled substances act [11000 - 11651]. Chapter 6. Offenses and penalties [11350 - 11392] Article 4. Miscellaneous Offenses and Provisions [11364 - 11376.5]. 1972.

  • California Health and Safety Code. Division 105. Communicable disease prevention and control [120100 - 122420]. Part 4. Human immunodeficiency virus (HIV) [120775 - 121349.3]. Chapter 18. Clean Needle and Syringe Exchange Program [121349 - 121349.3]. 1972.

  • Davis CS, Lieberman AJ, O'Kelley-Bangsberg M. Legality of drug checking equipment in the United States: A systematic legal analysis. Drug Alcohol Depend. 2022 May 1;234:109425. doi: 10.1016/j.drugalcdep.2022.109425. Epub 2022 Mar 22.

    PubMed 35344879
  • Controlled substances: paraphernalia: controlled substance testing.; 2022. https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=202120220AB1598.

  • Green TC, Park JN, Gilbert M, McKenzie M, Struth E, Lucas R, Clarke W, Sherman SG. An assessment of the limits of detection, sensitivity and specificity of three devices for public health-based drug checking of fentanyl in street-acquired samples. Int J Drug Policy. 2020 Mar;77:102661. doi: 10.1016/j.drugpo.2020.102661. Epub 2020 Jan 14.

    PubMed 31951925
  • McCrae K, Tobias S, Grant C, Lysyshyn M, Laing R, Wood E, Ti L. Assessing the limit of detection of Fourier-transform infrared spectroscopy and immunoassay strips for fentanyl in a real-world setting. Drug Alcohol Rev. 2020 Jan;39(1):98-102. doi: 10.1111/dar.13004. Epub 2019 Nov 19.

    PubMed 31746056
  • Ti L, Tobias S, Lysyshyn M, Laing R, Nosova E, Choi J, Arredondo J, McCrae K, Tupper K, Wood E. Detecting fentanyl using point-of-care drug checking technologies: A validation study. Drug Alcohol Depend. 2020 Jul 1;212:108006. doi: 10.1016/j.drugalcdep.2020.108006. Epub 2020 May 12.

    PubMed 32438280

Questions about this trial

What is this clinical trial studying?

A study testing MI-CHANCE (TS + FTIR + MI) and TS + FTIR + Flu and Hepatitis A Education in people with Overdose, run by University of California, San Diego at 1 site in United States.

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 9 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Risk rates of fatal and non-fatal overdose over 30 months (time frame: Through study completion, an average of 30 months). 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 NCT06855836, which also lists 24 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 6 Apr 2026.

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