A randomized clinical trial of a theory-based fentanyl overdose education and fentanyl test strip distribution intervention to reduce rates of opioid overdose: study protocol for a randomized controlled trial
| Autor: | Scott E. Hadland, Katie B. Biello, Brendan Jacka, Brandon D.L. Marshall, Susan G. Sherman, Edward Bernstein, Jesse L. Yedinak, Jane A. Buxton, Jacqueline E. Goldman |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Adult
medicine.medical_specialty Adolescent Motivational interviewing Psychological intervention 030508 substance abuse Medicine (miscellaneous) Fentanyl Heroin law.invention 03 medical and health sciences Young Adult Study Protocol 0302 clinical medicine Randomized controlled trial law Naloxone medicine Humans Pharmacology (medical) 030212 general & internal medicine Fentanyl test strip Aged Randomized Controlled Trials as Topic lcsh:R5-920 Illicitly manufactured fentanyl business.industry Behavior change Rhode Island Opioid overdose Middle Aged medicine.disease Analgesics Opioid Opiate Overdose Behavioral intervention Overdose prevention Emergency medicine North America Information-motivation-behavioral model 0305 other medical science business lcsh:Medicine (General) medicine.drug |
| Zdroj: | Trials Trials, Vol 21, Iss 1, Pp 1-10 (2020) |
| DOI: | 10.14288/1.0395089 |
| Popis: | Background Opioid overdose deaths involving synthetic opioids, particularly illicitly manufactured fentanyl, remain a substantial public health concern in North America. Responses to overdose events (e.g., administration of naloxone and rescue breathing) are effective at reducing mortality; however, more interventions are needed to prevent overdoses involving illicitly manufactured fentanyl. This study protocol aims to evaluate the effectiveness of a behavior change intervention that incorporates individual counseling, practical training in fentanyl test strip use, and distribution of fentanyl test strips for take-home use among people who use drugs. Methods Residents of Rhode Island aged 18–65 years who report recent substance use (including prescription pills obtained from the street; heroin, powder cocaine, crack cocaine, methamphetamine; or any drug by injection) (n = 500) will be recruited through advertisements and targeted street-based outreach into a two-arm randomized clinical trial with 12 months of post-randomization follow-up. Eligible participants will be randomized (1:1) to receive either the RAPIDS intervention (i.e., fentanyl-specific overdose education, behavior change motivational interviewing (MI) sessions focused on using fentanyl test strips to reduce overdose risk, fentanyl test strip training, and distribution of fentanyl test strips for personal use) or standard overdose education as control. Participants will attend MI booster sessions (intervention) or attention-matched control sessions at 1, 2, and 3 months post-randomization. All participants will be offered naloxone at enrolment. The primary outcome is a composite measure of self-reported overdose in the previous month at 6- and/or 12-month follow-up visit. Secondary outcome measures include administratively linked data regarding fatal (post-mortem investigation) and non-fatal (hospitalization or emergency medical service utilization) overdoses. Discussion If the RAPIDS intervention is found to be effective, its brief MI and fentanyl test strip training components could be easily incorporated into existing community-based overdose prevention programming to help reduce the rates of fentanyl-related opioid overdose. Trial registration ClinicalTrials.gov NCT04372238. Registered on 01 May 2020 |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|