Interim Buprenorphine Treatment to Bridge Waitlist Delays: Stage II Evaluation

NCT ID: NCT03420313

Last Updated: 2019-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2021-07-31

Brief Summary

Despite the demonstrated effectiveness of agonist treatment for opioid dependence and alarming recent increases in overdose deaths, waiting lists for treatment persist. In a Behavioral & Integrative Treatment Development pilot study, the investigators demonstrated the initial efficacy a novel Interim Buprenorphine Treatment (IBT) to mitigate the risks (e.g., illicit opioid use, IV drug use) associated with treatment delays. However, consistent with that R34 mechanism, our initial pilot study involved a limited sample size and was conducted at a single academic, well-controlled research clinic with an extensive history of research. It is important to replicate these very positive pilot results and begin to evaluate whether they generalize to less-controlled rural environments that are being so adversely impacted by the current opioid abuse epidemic. In this Stage II randomized parallel two-group trial, the investigators will evaluate the efficacy of IBT using a larger sample of 100 waitlisted opioid-dependent adults (50 IBT, 50 WLC). UVM will serve as the coordinating center and we will aim to partner with health centers and other convenience sites in rural Vermont counties to conduct study visits while overcoming barriers commonly encountered in rural areas (e.g., transportation issues, socioeconomic barriers). The proposed research builds directly on the promising Stage I results and has the potential to substantially reduce the vast individual and societal costs associated with opioid treatment delays.

Detailed Description

Despite the demonstrated effectiveness of agonist treatment for opioid dependence and alarming recent increases in overdose deaths, waiting lists for treatment persist. Opioid-dependent individuals can remain on waitlists for months, during which they are at substantial risk for illicit drug use, criminal activity, infectious disease, overdose and premature death. One effort to reduce these risks has been to extend interim methadone treatment (IMT; i.e., daily methadone without counseling) to individuals awaiting entry into a methadone program. IMT significantly reduces illicit opioid use and criminality during treatment delays. However, it is limited to licensed specialty clinics, requires daily visits, prohibits take-home doses and cannot exceed a 120-day duration. These regulatory restrictions have constrained the widespread use of IMT.

With a Behavioral & Integrative Treatment Development R34, the investigators have developed a novel Interim Buprenorphine Treatment (IBT) to mitigate the risks associated with treatment delays while surmounting the limitations noted above for methadone. It includes key components to permit delivery of potentially life-saving pharmacotherapy while minimizing nonadherence: (a) Buprenorphine (BUP) offers a regulatory and safety profile that is uniquely compatible with interim dosing. Participants receive BUP maintenance with bi-monthly clinic visits and the remaining doses dispensed at home via a secure computerized portable device (Med-O-Wheel, Addoz, Finland). Participants also receive (b) nightly calls from an automated Interactive Voice Response (IVR) phone system to assess any drug use, withdrawal and craving, (c) IVR-generated random call-backs for urinalysis and pill counts, and (d) HIV+Hepatitis education delivered via iPad.

Our Stage I pilot data strongly support the initial efficacy of this intervention. Among 50 waitlisted opioid-dependent adults randomized to IBT (n=25) or Waitlist Control (WLC; n=25) conditions for 12 weeks, 85%, 84% and 68% of IBT participants are abstinent at 4, 8 and 12-week assessments vs. 0%, 0% and 0% of WLC participants (p<.001). IBT participants also reported significantly greater reductions in illicit opioid use and IV drug use frequency and completing 96% of daily IVR calls and random call-backs. These outcomes represented a substantial first step towards the development of an intervention that can reduce individual and societal risks during delays to conventional treatment.

However, consistent with the R34 mechanism, our initial pilot study involved a limited sample size and was conducted at a single academic, well-controlled research clinic with an extensive history of research and a brief treatment duration. It is important to replicate these very positive pilot results and begin to evaluate whether they generalize to less-controlled rural environments that are being so adversely impacted by the current opioid abuse epidemic as well as over longer treatment durations. Important to underscore is that our IBT components (i.e., Med-O-Wheel, IVR, HIV+Hepatitis application) are highly transportable, which increases the potential of extending them to sites outside of the university setting while retaining efficacy.

Primary Aim: In this Stage II randomized parallel two-group trial, the investigators will evaluate the efficacy of IBT using a larger sample of 100 waitlisted opioid-dependent adults (50 IBT, 50 WLC). UVM will serve as the coordinating center and we will aim to partner with health centers and other convenience sites in rural Vermont counties to conduct study visits while overcoming barriers commonly encountered in rural areas (e.g., transportation issues, socioeconomic barriers). Participants randomized to IBT will receive the intervention described above for a duration of 24-weeks; WLC participants will remain on the waitlist for their treatment of choice but complete monthly assessments. It is hypothesized that IBT participants will achieve significantly greater illicit opioid abstinence relative to WLC participants.

The proposed research builds directly on the promising Stage I results and has the potential to substantially reduce the vast individual and societal costs associated with opioid treatment delays. By facilitating the eradication of waitlists, this project represents a significant departure from the status quo and stands to produce a fundamental shift in how treatment for opioid dependence is conceptualized and delivered.

Conditions

Opioid-use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interim Buprenorphine Treatment

Interim Buprenorphine Treatment includes (a) Maintenance treatment with Buprenorphine/ naloxone sublingual tablets with bi-monthly clinic visits for observed dosing and the remaining doses dispensed at home via a secure computerized portable device (Med-O-Wheel, Addoz, Finland).

(b) nightly calls from an automated Interactive Voice Response (IVR) phone system to assess any drug use, withdrawal and craving, (c) IVR-generated random call-backs for urinalysis and pill counts, and (d) HIV+Hepatitis education delivered via iPad. (e) monthly follow-up assessments

Group Type: EXPERIMENTAL

Buprenorphine/naloxone sublingual tablets

Intervention Type: DRUG

24-week maintenance with buprenorphine/naloxone sublingual tablets (plus other technology-assisted components described previously)

Waitlist Control

Waitlist Control participants will remain on the waitlist for their treatment of choice but complete the same monthly assessments.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Buprenorphine/naloxone sublingual tablets

24-week maintenance with buprenorphine/naloxone sublingual tablets (plus other technology-assisted components described previously)

Intervention Type: DRUG

Other Intervention Names

BUP

Eligibility Criteria

Inclusion Criteria

• For inclusion, participants must be >=18 years old, in good health, meet DSM-V criteria for opioid use disorder, provide an opioid-positive urine and be currently waitlisted with a community opioid treatment clinic or provider.

Exclusion Criteria

• Those with a significant psychiatric or medical illness that may interfere with consent or participation will be excluded, as will those who are pregnant or nursing. Those dependent on sedative-hypnotics will be excluded, due to the medical risks and notably low success rates with sedative-dependent opioid abusers (Stitzer & Chutuape, 1999).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Stacey C. Sigmon

Associate Professor, UVM Dept of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Vermont

Burlington, Vermont, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stacey C Sigmon, PhD

Role: CONTACT

ssigmon@uvm.edu

802-656-9987

Facility Contacts

Stacey C Sigmon, PhD

Role: primary

ssigmon@uvm.edu

802-656-9987

Susan Enos

Role: backup

senos@uvm.edu

802-656-8712

References

Sigmon SC, Peck KR, Batchelder SR, Badger GJ, Heil SH, Higgins ST. Technology-Assisted Buprenorphine Treatment in Rural and Nonrural Settings: Two Randomized Clinical Trials. JAMA Netw Open. 2023 Sep 5;6(9):e2331910. doi: 10.1001/jamanetworkopen.2023.31910.

Reference Type: DERIVED

PMID: 37755833 (View on PubMed)

Other Identifiers

1R01DA042790-01

Identifier Type: NIH

Identifier Source: org_study_id

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