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The Rhode Island Prescription and Illicit Drug Study (RAPIDS)

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ClinicalTrials.gov Identifier: NCT04372238
Recruitment Status : Recruiting
First Posted : May 1, 2020
Last Update Posted : January 27, 2021
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Brown University

Brief Summary:
This study will test the efficacy of a novel drug-checking intervention to prevent fatal and non-fatal overdose among people who use drugs (PWUD), who are 18-65 years old at the time of enrollment. The investigators will evaluate whether the incorporation of rapid fentanyl testing into a theory-driven overdose education and prevention intervention reduces rates of overdose compared to standard overdose education and naloxone distribution. Results from this study will significantly improve public health efforts to address the fentanyl overdose epidemic and reduce harms associated with exposure to drugs contaminated with fentanyl. This is a full clinical trial, building on the previously approved fentanyl-test-strip pilot study (2016-2017), the results of which have recently been published.(Krieger et al., 2018)

Condition or disease Intervention/treatment Phase
Opioid Overdose Drug Overdose Behavioral: RAPIDS Intervention Behavioral: Standard OEND Not Applicable

Detailed Description:

The investigators will assess the efficacy of the RAPIDS intervention on preventing overdose among PWUD. Participants will be randomized 1:1 to receive the RAPIDS intervention or the attention-matched control condition. Experimental arm participants will receive the RAPIDS intervention, which includes education about the dangers of illicitly manufactured fentanyl (IMF), motivational interviewing to increase willingness to use fentanyl test strips and engage in overdose risk reduction behaviors, hands-on training to use the test strips, and opportunities to plan and role- play how to implement overdose risk reduction behaviors upon receipt of a positive or negative test result. In the attention-matched control arm, participants will receive standardized overdose education and naloxone distribution (OEND) training. All participants will attend additional study visits at months 1,2,3,6, and 12. The primary endpoint will be the rate of self-reported overdose over the follow-up period. Secondary endpoints (e.g., overdose death) will be ascertained by data linkage to statewide overdose surveillance databases.

The primary aims of this study are to: 1) Assess the efficacy of the RAPIDS intervention in reducing rates of overdose among people who use drugs; 2) Examine the degree to which reductions in rates of overdose are mediated by increases in information, motivation, behavioral skills, and self-efficacy regarding fentanyl, rapid fentanyl testing, and harm reduction practices; and 3) Explore whether there is heterogeneity of treatment effect related to key participant characteristics.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants randomized to receive the RAPIDS intervention will receive fentanyl test strips and additional fentanyl-specific education. Both arms will receive standardized overdose prevention education and naloxone.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The biostatistician will be blinded to the intervention/control group assignment throughout the course of the study and the assignments. Additionally, the principal investigator will remain blinded to the randomization.
Primary Purpose: Prevention
Official Title: The Rhode Island Prescription and Illicit Drug Study Responding to Fentanyl and Associated Harms
Actual Study Start Date : August 31, 2020
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Arm Intervention/treatment
Experimental: RAPIDS intervention
Participants randomized to receive the RAPIDS intervention will receive a fentanyl specific behavioral intervention and a brief behavioral intervention to increase willingness to use fentanyl test strips and engage in overdose risk reduction behaviors, in addition to standard OEND.
Behavioral: RAPIDS Intervention
RAPIDS intervention combines a behavioral intervention along with hands-on training to use fentanyl test strips.

Behavioral: Standard OEND
In the attention-matched control arm, participants will receive standardized overdose education and naloxone distribution (OEND) training, with attention-control visits at 1, 2, and 3 months. Participants will receive a naloxone kit after completion of the first session, and information regarding where to obtain additional naloxone at subsequent visits. They will have contact with study staff at month 6 and 12 follow-up visits to capture outcome and covariate data.

Active Comparator: Standard OEND
In the control arm participants will receive standard overdose education and naloxone distribution (OEND).
Behavioral: Standard OEND
In the attention-matched control arm, participants will receive standardized overdose education and naloxone distribution (OEND) training, with attention-control visits at 1, 2, and 3 months. Participants will receive a naloxone kit after completion of the first session, and information regarding where to obtain additional naloxone at subsequent visits. They will have contact with study staff at month 6 and 12 follow-up visits to capture outcome and covariate data.




Primary Outcome Measures :
  1. Accidental non-fatal overdose in the past month [ Time Frame: 6 months post-randomization ]
    The rate of self-reported, non-fatal opioid related overdose, measured by survey questions at each follow up visit.

  2. Accidental non-fatal overdose in the past month [ Time Frame: 12 months post-randomization ]
    The rate of self-reported, non-fatal opioid related overdose, measured by survey questions at each follow up visit.


Secondary Outcome Measures :
  1. The number of fatal overdose events [ Time Frame: 12 months post-randomization ]
    The number of fatal overdoses experienced throughout 12 month enrollment in the study, measured using Rhode Island Department of Health data



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Reside in Rhode Island
  • Are able to complete interviews in English
  • Are able to provide informed consent
  • Self-report past 30 day heroin, illicit stimulants, counterfeit prescription pills, or injection drugs

Exclusion Criteria:

  • Participants who exclusively misuse medications obtained from a physician or diversion from someone else's prescription

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04372238


Contacts
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Contact: Brandon DL Marshall, PhD 401-863-6427 Brandon_marshall@brown.edu

Locations
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United States, Rhode Island
Brown University School of Public Health Recruiting
Providence, Rhode Island, United States, 02912
Contact: Jacqueline E Goldman, ScM    401-863-6970    jacqueline_goldman1@brown.edu   
Sponsors and Collaborators
Brown University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Brandon DL Marshall, PhD Brown University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brown University
ClinicalTrials.gov Identifier: NCT04372238    
Other Study ID Numbers: 1904002388
R01DA047975 ( U.S. NIH Grant/Contract )
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brown University:
Drug overdose
Substance-Related Disorders
Chemically-induced disorders
Fentanyl
analgesics, Opioids
Narcotics
Naloxone
Central Nervous System Depressants
Physiological Effects of Drugs
Additional relevant MeSH terms:
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Drug Overdose
Opiate Overdose
Substance-Related Disorders
Chemically-Induced Disorders
Opioid-Related Disorders
Narcotic-Related Disorders
Mental Disorders