Subthreshold Opioid Use Disorder Prevention (STOP) Trial

Summary

The Subthreshold Opioid Use Disorder Prevention (STOP) trial will test the efficacy of a primary care intervention to reduce opioid use and overdose risk, and prevent progression to OUD, in adults with unhealthy use of illicit or prescribed opioids. STOP is a collaborative care model. A cluster-randomized trial, conducted in 5 primary care sites, with 100 PCPs and 300adult primary care patients, will test the efficacy of STOP versus enhanced usual care (EUC). The STOP intervention, if proven efficacious, will provide a solution to preventing OUD among patients who are most at risk, thus addressing a key aspect of the current opioid crisis.

Conditions

• Opioid-use Disorder

Interventions

BEHAVIORAL

PCP brief advice

Brief advice will be delivered by the patient participant's PCP as part of the medical visit or via phone call. Before the encounter with the patient participant, PCPs will receive a brief printed summary report from the research staff. The summary advises the PCP that their patient participant screened positive for risky opioid use, lists the patient participant's screening results (TAPS Tool +/- COMM) and gives a suggested counseling script. The counseling script will include specific advice on opioid-related risks, will inform patient participants of resources to help them reduce their risk, and will include a recommendation to reduce their risk behavior.

BEHAVIORAL

Video doctor

During the baseline visit with the research staff, patient participants will view a video on tablet or desktop computer that reinforces the PCP's counseling. The video is a recording of a provider delivering brief advice about opioid use that includes the same elements covered in the summary report outlined above.

BEHAVIORAL

Telephone health coaching

All patient participants in the STOP arm will receive telephonic health coaching sessions at approximately 2- and 4-weeks post-baseline. Patient participants who may benefit from additional coaching (for example, those who do not improve or who experience clinical worsening of unhealthy opioid use) may receive additional coaching sessions (approximately 4 sessions) from the telephone health coach. Coaching is delivered from a centralized call center, by staff that receive standardized training and supervision. To the extent possible, calls will be scheduled at the patient participant's convenience (e.g., evenings, weekends).

BEHAVIORAL

Nurse Care Manager (NCM) intervention

NCMs will provide health education and counseling on risk reduction, overdose prevention and self-management skills. Patient participants will be asked to participate in a baseline visit with the NCM, which will occur on the same day as the baseline research visit if possible. The NCM continues working with patients in the STOP condition throughout their 12 months of study participation. Following the initial visit with the NCM, the frequency of visits depends on patient participant needs.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• NYU Langone Health

  lead OTHER

Principal Investigators

• Jennifer McNeely, MD · NYU Langone

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-25

Primary Completion

2023-11-15

Completion

2024-05-17

Countries

• United States

Study Locations