Substance Use DisordersNCT05889702
Kentucky Access to Recovery Evaluation
An observational study of Substance Use Disorders and Treatment Adherence and Compliance, run by Terry Bunn at 2 sites in United States.
Trial summary
Evaluate the long-term effectiveness of implementing vouchers as a linkage strategy in a population requiring recovery support services (RSS) when no other funding sources are available. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders, Treatment Adherence and Compliance
- What is being tested?
- KATR Linkage Strategy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 458 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jul 2023to 24 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: individuals in underserved areas with incomes at or below the 200% poverty level, individuals with prior criminal-justice involvement, veterans, and pregnant and parenting populations, with illicit SUD
Who may be able to join
- be in SUD treatment or have completed within the past year SUD treatment for opioid use disorder or stimulant use disorder or have a history of overdose from opioid use
- be a first-time participant in KATR
- be in early stages of recovery (less than one year in recovery)
- be a resident of a KATR service county
- be at or below the 200% federal poverty level
- not have financial resources available through other funding mechanisms for RSSs
- be 18 years of age and older
- be in need of recovery supports that will enhance their likelihood of staying in recovery
Who cannot join
- Under 18
- Participated in KATR previously
Trial locations and contacts
2 sites in 1 country.
United States2 sites
FAHE
Berea, Kentucky, 40403
University of Kentucky
Lexington, Kentucky, 40506
About this study
Official title: Evaluation of the Kentucky Access to Recovery (KATR) Linkage Strategy
Evaluate the long-term effectiveness of implementing vouchers as a linkage strategy in a population requiring recovery support services (RSS) when no other funding sources are available. A within-subjects study design will be used to test the effectiveness of the Kentucky Access to Recovery (KATR) last resort voucher linkage approach to reduce the risk of nonfatal and fatal overdoses by (a) increasing an individual's recovery capital; (b) reducing resumption of illicit substance use; and (c) promoting relinking to RSSs if illicit substance use is resumed.
- Being tested
- KATR Linkage Strategy
- Keywords
- Support Services, Recovery, Opioid Overdose, Addiction, Social Services, Appalachia
- Medical subject headings
- Substance-Related Disorders, Treatment Adherence and Compliance, Opiate Overdose, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KATR Linkage StrategyBehavioural
The Kentucky ATR (KATR) strategy is a 25-county program that links county residents at or below the 200% national poverty level who have an illicit SUD and are in treatment or early recovery to evidence-based RSSs such as recovery housing, and to other RSSs.
The KATR linkage approach uses vouchers as a linkage strategy for individuals in SUD treatment who have no other funding options to acquire critical RSSs. As such, KATR's linkage through vouchers is a "last resort" approach for linking to RSSs.
| Study group | Role | What they receive |
|---|---|---|
| KATR Clients | participants in the early stages of recovery and in substance use disorder (SUD) treatment; or those that have completed within the past year SUD treatment for opioid use disorder or stimulant use disorder or have a history of overdose from opioid use. Receives: Behavioral: KATR Linkage Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Recovery Capital per person
Recovery capital will be assessed using the Brief Assessment of Recovery Capital-10 (BARC-10); 10 item survey unidimensional measure of recovery capital, scores may range from 6-60 at any given time. Evaluation of the measure suggests that individuals who have a higher score are likely to reach or sustain a year or longer of recovery from substance use disorder.
Measured: Enrollment, Up to 6 months, 3 months post discharge, and 12 months post enrollment
Change in number of drug overdoses per person
Number of drug overdoses will be assessed with the following survey question: In the past 30 days, did you experience an overdose or take too much of a substance that resulted in needing supervision or medical attention?
Measured: Enrollment, Up to 6 months, 3 months post discharge, and 12 months post enrollment
Change in number of days of illicit substance use per person
Number of days illicit substance use will be assessed with the following survey question: During the past 30 days, how many days have you used any substance
Measured: Enrollment, Up to 6 months, 3 months post discharge, and 12 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start3 Jul 2023
- Primary completion24 Feb 2025
- Study completion24 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terry Bunn
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Terry Bunn, University of Kentucky
- Investigators
- Terry Bunn, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889702
- Sponsor's protocol ID
- 81811
- Other IDs
- R01CE003513-01-00, R01CE003513-01
- Status last verified
- Apr 2025
- First submitted
- 23 May 2023
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Kentucky Access to Recovery (KATR) Linkage Strategy
- ClinicalTrials.gov ID
- NCT05889702
- Acronym / sponsor ID
- 81811
- Keywords
- Support Services, Recovery, Opioid Overdose, Addiction, Social Services, Appalachia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Terry BunnUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the long-term effectiveness of implementing vouchers as a linkage strategy in a population requiring recovery support services (RSS) when no other funding sources are available. A within-subjects study design will be used to test the effectiveness of the Kentucky Access to Recovery (KATR) last resort voucher linkage approach to reduce the risk of nonfatal and fatal overdoses by (a) increasing an individual's recovery capital; (b) reducing resumption of illicit substance use; and (c) promoting relinking to RSSs if illicit substance use is resumed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KATR Clients | – | Behavioral: KATR Linkage Strategyparticipants in the early stages of recovery and in substance use disorder (SUD) treatment; or those that have completed within the past year SUD treatment for opioid use disorder or stimulant use disorder or have a history of overdose from opioid use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- individuals in underserved areas with incomes at or below the 200% poverty level, individuals with prior criminal-justice involvement, veterans, and pregnant and parenting populations, with illicit SUD
Key inclusion criteria (8 listed)
- be in SUD treatment or have completed within the past year SUD treatment for opioid use disorder or stimulant use disorder or have a history of overdose from opioid use
- be a first-time participant in KATR
- be in early stages of recovery (less than one year in recovery)
- be a resident of a KATR service county
- be at or below the 200% federal poverty level
Key exclusion criteria (2 listed)
- Under 18
- Participated in KATR previously
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KATR Linkage StrategyThe Kentucky ATR (KATR) strategy is a 25-county program that links county residents at or below the 200% national poverty level who have an illicit SUD and are in treatment or early recovery to evidence-based RSSs such as recovery housing, and to other RSSs. The KATR linkage approach uses vouchers as a linkage strategy for individuals in SUD treatment who have no other funding options to acquire critical RSSs. As such, KATR's linkage through vouchers is a "last resort" approach for linking to RSSs. | Behavioural | KATR Clients |
Primary outcome
Change in Recovery Capital per person
Time frame: Enrollment, Up to 6 months, 3 months post discharge, and 12 months post enrollment
Recovery capital will be assessed using the Brief Assessment of Recovery Capital-10 (BARC-10); 10 item survey unidimensional measure of recovery capital, scores may range from 6-60 at any given time. Evaluation of the measure suggests that individuals who have a higher score are likely to reach or sustain a year or longer of recovery from substance use disorder.
Change in number of drug overdoses per person
Time frame: Enrollment, Up to 6 months, 3 months post discharge, and 12 months post enrollment
Number of drug overdoses will be assessed with the following survey question: In the past 30 days, did you experience an overdose or take too much of a substance that resulted in needing supervision or medical attention?
Change in number of days of illicit substance use per person
Time frame: Enrollment, Up to 6 months, 3 months post discharge, and 12 months post enrollment
Number of days illicit substance use will be assessed with the following survey question: During the past 30 days, how many days have you used any substance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry Bunn, PhD principal investigator
University of Kentucky
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Use Disorders and Treatment Adherence and Compliance, run by Terry Bunn at 2 sites 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 8 inclusion and 2 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: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Recovery Capital per person (time frame: Enrollment, Up to 6 months, 3 months post discharge, and 12 months post enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2025.