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OpenTrials
Completed

NCT Number: NCT03969238

Utilizing Helpline for Opioid Dependence Treatment

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UVA Center for Leading Edge Addiction Research

Charlottesville, Virginia, 22903, United States

About this study

The proposed specific aims are to:

  • Test if the helpline is a resourceful tool for patients with opioid use disorder looking for referrals and support to access treatment. The opioid helpline will provide individuals with opioid use disorder seeking treatment, direct access to a live person who can answer questions regarding referrals and various treatment programs. The helpline will also follow-up on treatment compliance and offer support and motivational techniques for these individuals to stay engaged in treatment
  • Test if the helpline is a resourceful tool for patients with new onset of pain or chronic pain being prescribed opioids. The opioid helpline will provide these individuals the necessary educational materials on managing pain safely while avoiding misuse. It will offer free imagery guided meditation and other non-pharmacological tools to help with pain management.
  • Test if providers find the opioid helpline helpful and resourceful for their practice and are willing to refer patients to the helpline.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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.

Primary outcomes

  1. Participant Opioid Helpline Survey

    Time frame: up to a year

    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.

  2. Provider Opioid Helpline Survey

    Time frame: up to a year

    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.

Secondary outcomes

  1. Number of participants reached versus called.

    Time frame: up to a year

    Total number of contacts to the Helpline compared to the number that prescreened and the number consented.

  2. Number of participants who continued to access the services of Helpline

    Time frame: up to a year

    The investigator will measure the number of participants who continued to access the services of Helpline up to a year.

  3. New General Self-Efficacy Measure

    Time frame: up to a year

    By using this survey, the investigator will determine the participant's ability to handle the situation that prompted the participant to call the Helpline originally.

  4. Opioid Helpline Study Screen Form

    Time frame: up to a year

    This will be use to collect demographic information for individuals who self-identify as needing help or resources from the Helpline.

  5. Referral follow-ups

    Time frame: up to a year

    Assess which referrals were followed up on by the participants.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 31, 2019
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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