Opioid DependenceNCT03969238
Utilizing Helpline for Opioid Dependence Treatment
An observational study of Opioid Dependence, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Dependence
- What is being tested?
- Helpline
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2019to 4 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UVA Center for Leading Edge Addiction Research
Charlottesville, Virginia, 22903
About this study
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.
Read the detailed description
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.
- Conditions
- Opioid Dependence
- Being tested
- Helpline
- Keywords
- opioid dependence, pain management
- Medical subject headings
- Opioid-Related Disorders, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HelplineBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Helpline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to a year
Secondary outcomes (5)
Number of participants reached versus called.
Total number of contacts to the Helpline compared to the number that prescreened and the number consented.
Measured: up to a year
Number of participants who continued to access the services of Helpline
The investigator will measure the number of participants who continued to access the services of Helpline up to a year.
Measured: up to a year
New General Self-Efficacy Measure
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.
Measured: up to a year
Opioid Helpline Study Screen Form
This will be use to collect demographic information for individuals who self-identify as needing help or resources from the Helpline.
Measured: up to a year
Referral follow-ups
Assess which referrals were followed up on by the participants.
Measured: up to a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start25 Jun 2019
- Primary completion4 May 2021
- Study completion4 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nassima Ait-Daoud Tiouririne, University of Virginia
- Investigators
- Nassima Ait-Daoud Tiouririne, M.D., Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969238
- Sponsor's protocol ID
- 21376
- Status last verified
- May 2026
- First submitted
- 27 Mar 2019
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Helpline for Opioid Dependence Treatment
- ClinicalTrials.gov ID
- NCT03969238
- Acronym / sponsor ID
- 21376
- Conditions
- Opioid Dependence
- Keywords
- opioid dependence, pain management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 31 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients/Providers | – | Behavioral: HelplineOf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
- Providers outside the designated regions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HelplineThis 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. | Behavioural | Patients/Providers |
Primary outcome
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.
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.
5 secondary outcomes
Number of participants reached versus called.
Time frame: up to a year
Number of participants who continued to access the services of Helpline
Time frame: up to a year
New General Self-Efficacy Measure
Time frame: up to a year
Opioid Helpline Study Screen Form
Time frame: up to a year
Referral follow-ups
Time frame: up to a year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
Related trials for Opioid Dependence
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Active, not recruiting
The MOUD Plus Pilot: Counseling and Peer Support to Support Retention for Medically Complex Patients With Opioid Use Disorder Seen In Primary Care
Opioid Dependence, Substance Abuse Disorders
Recruiting
Transcranial Direct Current Stimulation (tDCS) for Treatment of Substance Use Disorder
Cocaine Use Disorder, Cocaine Dependence
Active, not recruiting
Neuromodulation and Cognitive Training in Opioid Use Disorder
Opioid-use Disorder, Opioid Dependence
RecruitingObservational study
fMRI and Opioid Abstinence
Drug Use Disorder, Opioid Dependence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nassima Ait-Daoud Tiouririne, M.D. principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Dependence, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Opioid Helpline Survey (time frame: up to a year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026; AzTrials last refreshed its copy on 2 Nov 2026.