Utilizing Helpline for Opioid Dependence Treatment

NCT03969238 | Completed

• 1 other identifier: 21376
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The investigator propose to develop an opioid telephone helpline, where trained counselors and educators provide referral, educational and targeted interventions and support to individuals interested in addressing their addiction or needing help with managing their pain. The proposed application builds on "tobacco quit line" efforts, a nationally-adopted telephone-based service, providing education materials, access to cessation medication and counseling against tobacco use. Similar to tobacco quit line; the proposed telephone based services will remove barriers to treatment as they help individuals at the exact time of need. The helpline will also educate individuals with new onset pain about pain expectations, relaxation techniques, use of pharmacology and psychotherapy for treatment in addition to providing support for coping and reducing dependency on prescription opioids. It will be a low cost, easily accessible and utilizable technology to augment the clinical outcome of medication assisted treatment of opioid use disorder and pain management.

Conditions

Opioid Dependence

Keywords

opioid dependence; pain management

Outcome Measures

Primary Outcomes (2)

• Participant Opioid Helpline Survey

  Primary outcomes measure the rating of the Helpline by the patients. They will be sent surveys that will ask the patients to rate the services they receive on a scale of 1 to 10, with 1 meaning they are very dissatisfied and 10 meaning they are very satisfied.

  up to a year

• Provider Opioid Helpline Survey

  Primary outcomes measure the rating of the Helpline by the providers. They will be sent surveys that will ask the providers to rate the services they receive on a scale of 1 to 10, with 1 meaning they are very dissatisfied and 10 meaning they are very satisfied.

  up to a year

Secondary Outcomes (5)

• Number of participants reached versus called.

  up to a year

• Number of participants who continued to access the services of Helpline

  up to a year

• New General Self-Efficacy Measure

  up to a year

• Opioid Helpline Study Screen Form

  up to a year

• Referral follow-ups

  up to a year

Study Arms (1)

Patients/Providers

Of the1,000 participants: (1) 900 will enroll as participants who use the helpline resources via verbal consent and (2) 100 will enroll as providers via online consent prior to survey data collection.

Behavioral: Helpline

Interventions

Helpline BEHAVIORAL

This helpline will aim to provide patients with new diagnosis of pain who are prescribed opioids, access to education, support and free behavioral technique to help manage their pain such as mindfulness exercises. For those with opioid use disorder, the helpline will offer support in the form of education about the disorder, opioid withdrawal symptoms, risks of overdoses, and a variety of services such as help reach appropriate care with MAT licensed providers, information on FDA-approved MAT and naloxone, and, in some cases, behavioral intervention to keep patients engaged in treatment. The opioid helpline will provide a central resource for direct services and a portal for community services. It will also serve as a referral resource for health-care professionals.

Patients/Providers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We plan to pilot this model in a small rural area with low accessibility to specialized treatment. We will specifically target the area of county of Wise as it is an area with one of the highest rate of opioid addiction and overdose related deaths in the state. UVA hospital: we plan to pilot this model at UVA hospital because it is a health care system offering care to a diverse population from urban and rural areas. The providers will be educated regarding the goals and objectives of the helpline: Any specialty physicians, nurses including dentists that prescribes opioids within Virginia They will be asked to have flyers about the helpline in their office and refer patients who are prescribed opioids to get more support from the helpline.

You may qualify if:

• Participant Criteria:
• Age greater than or equal to 18 years.
• A formal diagnosis of Opioid Use Disorder (OUD) by a health care provider or
• If no formal diagnosis of OUD, having a self-reported concern with opioid use or addiction.
• An individual seeking to reduce opioid use.
• An individual concerned about opioids prescribed for management of new-onset pain or chronic pain.
• Provider Criteria:
• University of Virginia: Providers of any specialties within VA including dentists that prescribes opioids.
• County of Wise: Providers of any specialties including dentists that prescribes opioids.

You may not qualify if:

• Participant Criteria:
• Individuals under 18 years of age.
• Individuals seeking treatment for non-opioid substance use disorders
• Individuals who have no pain issues
• Individuals located outside of Virginia.
• Provider Criteria:
• Providers outside the designated regions.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

UVA Center for Leading Edge Addiction Research

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Agnosia

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nassima Ait-Daoud Tiouririne, M.D.

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Director of UVA Center for Leading Edge Addiction Research

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: May 31, 2019
• Study Start: June 25, 2019
• Primary Completion: May 4, 2021
• Study Completion: May 4, 2021
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)