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Utilizing Helpline for Opioid Dependence Treatment

2026年5月22日 更新者:Nassima Ait-Daoud Tiouririne、University of Virginia
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.

調査の概要

状態

完了

介入・治療

詳細な説明

The proposed specific aims are to:

  1. 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
  2. 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.
  3. Test if providers find the opioid helpline helpful and resourceful for their practice and are willing to refer patients to the helpline.

研究の種類

観察的

入学 (実際)

31

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Virginia
      • Charlottesville、Virginia、アメリカ、22903
        • UVA Center for Leading Edge Addiction Research

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

Inclusion Criteria:

Participant Criteria:

  1. Age greater than or equal to 18 years.
  2. A formal diagnosis of Opioid Use Disorder (OUD) by a health care provider or
  3. If no formal diagnosis of OUD, having a self-reported concern with opioid use or addiction.
  4. An individual seeking to reduce opioid use.
  5. An individual concerned about opioids prescribed for management of new-onset pain or chronic pain.

Provider Criteria:

  1. University of Virginia: Providers of any specialties within VA including dentists that prescribes opioids.
  2. County of Wise: Providers of any specialties including dentists that prescribes opioids.

Exclusion Criteria:

Participant Criteria:

  1. Individuals under 18 years of age.
  2. Individuals seeking treatment for non-opioid substance use disorders
  3. Individuals who have no pain issues
  4. Individuals located outside of Virginia.

Provider Criteria:

Providers outside the designated regions.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
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.
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Participant Opioid Helpline Survey
時間枠: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.
up to a year
Provider Opioid Helpline Survey
時間枠: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.
up to a year

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of participants reached versus called.
時間枠:up to a year
Total number of contacts to the Helpline compared to the number that prescreened and the number consented.
up to a year
Number of participants who continued to access the services of Helpline
時間枠:up to a year
The investigator will measure the number of participants who continued to access the services of Helpline up to a year.
up to a year
New General Self-Efficacy Measure
時間枠: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.
up to a year
Opioid Helpline Study Screen Form
時間枠: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.
up to a year
Referral follow-ups
時間枠:up to a year
Assess which referrals were followed up on by the participants.
up to a year

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Nassima Ait-Daoud Tiouririne, M.D.、University of Virginia

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2019年6月25日

一次修了 (実際)

2021年5月4日

研究の完了 (実際)

2021年5月4日

試験登録日

最初に提出

2019年3月27日

QC基準を満たした最初の提出物

2019年5月28日

最初の投稿 (実際)

2019年5月31日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月27日

QC基準を満たした最後の更新が送信されました

2026年5月22日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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