TY - JOUR
KW - Behavioral intervention
KW - Fentanyl test strip
KW - Illicitly manufactured fentanyl
KW - Information-motivation-behavioral model
KW - Motivational Interviewing
KW - opioid overdose
KW - Overdose prevention
KW - randomized controlled trial
AU - B. P. Jacka
AU - J. E. Goldman
AU - J. L. Yedinak
AU - E. Bernstein
AU - S. E. Hadland
AU - J. A. Buxton
AU - S. G. Sherman
AU - K. B. Biello
AU - B. D. L. Marshall
A1 - 
AB - 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.
AD - Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.; Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.; Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.; Department of Medicine, Boston University School of Medicine, Boston, Massachusetts, USA.; School of Public Health, Boston University, Boston, Massachusetts, USA.; Grayken Center for Addiction, Boston Medical Center, Boston, Massachusetts, USA.; Department of Pediatrics, Boston Medicine Center, Boston, Massachusetts, USA.; Division of General Pediatrics, Department of Pediatrics, Boston University School of Medicine, Boston, Massachusetts, USA.; School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada.; British Columbia Centre for Disease Control, Vancouver, British Columbia, Canada.; Department of Health, Behavior, and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.; Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.; Department of Behavioral and Social Sciences, School of Public Health, Brown University, Providence, Rhode Island, United States.; Fenway Institute, Fenway Health, Boston, Massachusetts, USA.; Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA. brandon_marshall@brown.edu.
BT - Trials
C5 - Healthcare Disparities; Measures; Opioids & Substance Use
CP - 1
DO - 10.1186/s13063-020-04898-8
IS - 1
JF - Trials
LA - eng
M1 - Journal Article
N2 - 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.
PY - 2020
SN - 1745-6215; 1745-6215
SP - 020
EP - 8
EP - 976+
T1 - 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
T2 - Trials
TI - 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
U1 - Healthcare Disparities; Measures; Opioids & Substance Use
U2 - 33243291
U3 - 10.1186/s13063-020-04898-8
VL - 21
VO - 1745-6215; 1745-6215
Y1 - 2020
Y2 - Nov 26
ER -