Opioid-Related DisordersNCT03526380
The OPT-IN Project
A study testing Behavioral: the OPT-IN Intervention in people with Opioid-Related Disorders, run by University of Michigan at 1 site in United States.
Trial summary
Prescription opioid overdose represents a public health crisis. A number of efforts have been implemented to address opioid prescribing and opioid risk mitigation strategies for prescribers, but relatively few efforts have sought to address this problem directly with individuals who use opioids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-Related Disorders
- What is being tested?
- Behavioral: the OPT-IN Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2018to 30 Jun 2020
- Phase
- Interventional
- 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
Who may be able to join
- Speaks English Fluently
- Receiving services at one of the investigator's partner sites
- History of opioid use
Who cannot join
- Medically unstable
- Prisoners
- Inability to speak and understand English
- Inability to give informed, voluntary, written consent for any reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Translation of Opiate Overdose Prevention Strategies
Prescription opioid overdose represents a public health crisis. A number of efforts have been implemented to address opioid prescribing and opioid risk mitigation strategies for prescribers, but relatively few efforts have sought to address this problem directly with individuals who use opioids. This gap likely fails to fully address the inherent reinforcing nature of the medications that make it challenging to reduce use.
The specific aim of this study is to pilot test a toolkit that pairs an intervention with the distribution of naloxone. External facilitation (supervision check-ins) will aid translation to delivery by non-research staff. Firstly, data will be collected from participants over time as a control group, prior to training site staff. Next, non-research staff will be trained on the intervention. Staff at the site will use the online "toolkit" developed in the beginning of this project to deliver the interventions and naloxone to their clients/patients as part of usual care. After staff at the site(s) are trained, additional data will be collected from participants during the intervention period and after 3-months.
Read the detailed description
Based on feedback from non-research site staff, the OPT-IN Project implementation package was tailored for optimal delivery in the site setting. The translation strategy will be evaluated using the RE-AIM framework, which includes Reach (e.g., number of individuals receiving intervention), Effectiveness (e.g., patient/client outcomes), Adoption (e.g., numbers trained), Implementation (e.g., fidelity of intervention delivery) and Maintenance (e.g., sustained in routine practice over time) with mixed qualitative and quantitative methods with intervention recipients.
- Conditions
- Opioid-Related Disorders
- Being tested
- Behavioral: the OPT-IN Intervention
- Keywords
- Drug overdose, Substance-Related Disorders, Chemically-Induced Disorders, Risk Reduction Behavior, Harm Reduction
- Medical subject headings
- Opioid-Related Disorders, Drug Overdose, Substance-Related Disorders, Chemically-Induced Disorders, Risk Reduction Behavior, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: the OPT-IN InterventionBehavioural
A private one-on-one brief motivational interviewing intervention administered by non-research staff at community organizations. This will take up to 30 minutes to complete. The goal of the intervention is to improve opioid safety and reduce related overdoses among those who has a history of misusing opioids (prescription and illicit). The session will use techniques to change behavior in a respectful, non-confrontational, and non-judgmental manner. This intervention will also seek to empower participants by providing content on bystander response as well as peer outreach, which emphasizes ways to discuss overdose risk with others at risk for overdose.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants receive the OPT-IN Brief Intervention. Receives: Behavioral: Behavioral: the OPT-IN Intervention |
| Control | No intervention | Participants will only complete the baseline and follow-up surveys. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overdose Risk Behaviors (ORB)
The ORB measures change over time for prescription opioid use, specific to type of opioid use, combination with other substances, route, and if they use alone. This scale is a total sum of 9 items assessing participant's self-report of engaging in behavior that increases risk for overdose. Higher scores indicate greater risk for overdose. The range for this measure is 0 to 32 in one assessment.
Measured: 3 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start11 Oct 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Amy S.B. Bohnert, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526380
- Sponsor's protocol ID
- R49CE002099
- Status last verified
- Aug 2020
- First submitted
- 3 May 2018
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation of Opiate Overdose Prevention Strategies
- ClinicalTrials.gov ID
- NCT03526380
- Acronym / sponsor ID
- R49CE002099
- Conditions
- Opioid-Related Disorders
- Keywords
- Drug overdose, Substance-Related Disorders, Chemically-Induced Disorders, Risk Reduction Behavior, Harm Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 16 May 2018 (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.
Prescription opioid overdose represents a public health crisis. A number of efforts have been implemented to address opioid prescribing and opioid risk mitigation strategies for prescribers, but relatively few efforts have sought to address this problem directly with individuals who use opioids. This gap likely fails to fully address the inherent reinforcing nature of the medications that make it challenging to reduce use.
The specific aim of this study is to pilot test a toolkit that pairs an intervention with the distribution of naloxone. External facilitation (supervision check-ins) will aid translation to delivery by non-research staff. Firstly, data will be collected from participants over time as a control group, prior to training site staff. Next, non-research staff will be trained on the intervention. Staff at the site will use the online "toolkit" developed in the beginning of this project to deliver the interventions and naloxone to their clients/patients as part of usual care. After staff at the site(s) are trained, additional data will be collected from participants during the intervention period and after 3-months.
Detailed description
Based on feedback from non-research site staff, the OPT-IN Project implementation package was tailored for optimal delivery in the site setting. The translation strategy will be evaluated using the RE-AIM framework, which includes Reach (e.g., number of individuals receiving intervention), Effectiveness (e.g., patient/client outcomes), Adoption (e.g., numbers trained), Implementation (e.g., fidelity of intervention delivery) and Maintenance (e.g., sustained in routine practice over time) with mixed qualitative and quantitative methods with intervention recipients.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Behavioral: the OPT-IN InterventionParticipants receive the OPT-IN Brief Intervention. |
| Control | No intervention | –Participants will only complete the baseline and follow-up surveys. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Speaks English Fluently
- Receiving services at one of the investigator's partner sites
- History of opioid use
Key exclusion criteria (4 listed)
- Medically unstable
- Prisoners
- Inability to speak and understand English
- Inability to give informed, voluntary, written consent for any reason
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 |
|---|---|---|
| Behavioral: the OPT-IN InterventionA private one-on-one brief motivational interviewing intervention administered by non-research staff at community organizations. This will take up to 30 minutes to complete. The goal of the intervention is to improve opioid safety and reduce related overdoses among those who has a history of misusing opioids (prescription and illicit). The session will use techniques to change behavior in a respectful, non-confrontational, and non-judgmental manner. This intervention will also seek to empower participants by providing content on bystander response as well as peer outreach, which emphasizes ways to discuss overdose risk with others at risk for overdose. | Behavioural | Treatment |
Primary outcome
Overdose Risk Behaviors (ORB)
Time frame: 3 months post-baseline
The ORB measures change over time for prescription opioid use, specific to type of opioid use, combination with other substances, route, and if they use alone. This scale is a total sum of 9 items assessing participant's self-report of engaging in behavior that increases risk for overdose. Higher scores indicate greater risk for overdose. The range for this measure is 0 to 32 in one assessment.
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 13 Aug 2020.
Related trials for Opioid-Related Disorders
Not yet recruitingEarly Phase 1
Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
Opioid Use Disorder, Alcohol Intoxication
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Active, not recruitingObservational study
Cannabis Use and Outcomes in Black and White Patients With Cancer
Cancer
RecruitingObservational study
Outcome Inference in the Sensory Preconditioning Task in Opioid-Use Disorder
Opioid-Related Disorders, Drug Addiction
RecruitingPhase 2
A Study of Cebranopadol for Opioid Withdrawal Symptoms in Adults With Chronic Pain
Chronic Pain, Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: the OPT-IN Intervention in people with Opioid-Related Disorders, run by University of Michigan 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 3 inclusion and 4 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 13 Aug 2020. 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?
Overdose Risk Behaviors (ORB) (time frame: 3 months post-baseline). 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 13 Aug 2020.