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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05776823
Other study ID # 274818
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date May 5, 2023
Est. completion date September 30, 2024

Study information

Verified date February 2024
Source University of Arkansas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the impact of a pharmacist-led intervention to expand access to medications for opioid use disorder (MOUD) on racial/ethnic differences in opioid-related overdose among individuals diagnosed with opioid use disorder (OUD) currently incarcerated in a carceral setting. In this study, participants will be screened for opioid use, trained to administer Narcan nasal spray, receive motivational counseling and referral to treatment post-release from a carceral setting (a Re-Entry program) into the community.


Description:

The main objectives of this study are: 1. To increase understanding of racial/ethnic differences in the prevalence of OUD. 2. To test if a pharmacist-led intervention is more effective than a substance use counselor (lay person) in increasing knowledge and confidence among different racial/ethnic groups related to administering Narcan nasal spray in an opioid overdose situation. 3. To test if a pharmacist-delivered an evidence-based intervention, q brief intervention and referral to treatment (BIRT) versus standard medication counseling (SMC) is more effective in increasing access to MOUD.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 480
Est. completion date September 30, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria Narcan Training: - a Re-Entry program participant 7-14 days from release from carceral setting - provide collateral contact information for =2 persons (to ensure consistent contact/follow up) - have a reliable landline or mobile phone to be contacted by pharmacist - plan to remain in the Little Rock area for at least 6 months - able to read and write English - able to provide informed consent - possesses manual dexterity; physical ability to roll a person onto her/his/their back and side - have no allergy to naloxone hydrochloride (active ingredient in Narcan nasal spray)- - identified on the RODS screener as positive for OUD. BIRT/SMC: - a Re-Entry program participant 7-14 days from release from the carceral setting - provide contact information for =2 persons (to ensure consistent contact/follow -up) - have a reliable landline or mobile phone to be contacted by pharmacist - plan to remain in the Little Rock area for at least 6 months - able to read and write English; able to provide informed consent - identified with OUD. Exclusion Criteria: Narcan training: - not a RE-entry program participant - identified substance use disorders other than OUD BIRT/SMC: - not a RE-entry program participant - identified substance use disorders other than OUD

Study Design


Intervention

Behavioral:
Pharmacist Narcan Training
A 20-45-minute didactic presentation conducted with a skills training component designed to demonstrate appropriate administration of the Narcan nasal spray.
BIRT
BIRT participants will receive a 30-45-minute session delivered by the pharmacist to introduce and encourage treatment options, MOUD information, OUD information, and treatment facility information (i.e., flyers (RDD study/CAST clinic/State Opioid Response III funded agencies) and educational materials), and a referral to treatment/linkage to service providers.
SMC
SMS participants will receive a 5-10-minute counseling session delivered by the pharmacist providing MOUD information, OUD information, and treatment facility information (i.e., flyers (RDD study/CAST clinic/State Opioid Response III funded agencies) and educational materials).
Substance Use Counselor Narcan Training
A 20-45-minute didactic presentation conducted with a skills training component designed to demonstrate appropriate administration of the Narcan nasal spray.

Locations

Country Name City State
United States Pulaski County Regional Detention Center Little Rock Arkansas

Sponsors (1)

Lead Sponsor Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Opioid overdose training Participants' knowledge about opioid overdose and confidence to recognize and respond to opioid overdose situations as a function of the trainer. Participants will complete a brief validated survey, the adapted Perceived Competence Scale. The questions on the survey are rated on a 7-point scale and participants indicate how true four statements are about their ability to recognize and respond to overdoses: the scale, 1 (not at all true) to 7 (very true). at month 6
Primary Retention Participants, regardless of treatment arm, will receive follow-up telephone interviews at 6 months post-release from the carceral setting into the community. Interviews will address the primary question whether MOUD treatment was initiated and maintained. at month 6
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