Following Outcomes Remotely Within Addiction Recovery Domains

Opioid Use Disorder Clinical Trial

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Official title:

CTN-0126 Following Outcomes Remotely Within Addiction Recovery Domains

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06001437
• Other study ID #: 2023P000766
• Secondary ID: 3UG1DA015831-21S
• Status: Recruiting
• Start date: September 2, 2023
• Est. completion date: July 2027

Study information

• Verified date: January 2024
• Source: Mclean Hospital
• Contact: Rebecca McHugh
• Phone: 617-855-2000
• Email: kmchugh[@]mclean.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to describe outcome of people with opioid use disorder over the long-term by collecting monthly and yearly data on their recovery. Adults with opioid use disorder who participate will complete surveys monthly online and once per year by phone about their substance use, mental health, treatment involvement and functioning. The goal of this study is to better understand how people with opioid use disorder recover over time to improve intervention for this group.

Description:

This is a longitudinal follow-up study that will collect yearly outcomes data on adults with opioid use disorder (OUD) who participated one of two prior clinical trials in the NIDA Clinical Trials Network. This longitudinal, observational study will entail annual phone and online assessments of domains of interest (e.g., substance use, treatment engagement) as well as monthly assessments that are distributed via text messaging and email to be completed electronically by the participant. No participant randomization will occur for this study, and study data will be considered observational in nature. We aim to characterize the long-term course of OUD and to evaluate the long-term course and recovery of OUD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: July 2027
• Est. primary completion date: July 2027
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Be an enrolled participant in one of two applicable clinical trials and be no longer than 24 months after the final expected assessment for that trial.

2. Be willing and able to provide locator information for survey distribution (mobile number and/or email address).

3. Be willing to allow the linkage of prior clinical trial study data to the current study record.

Exclusion Criteria:

1. Unable to understand or communicate to complete consent or study assessments.

2. Are currently in jail, prison or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities.

3. Other factors that would cause harm or increased risk to the participant or close contacts or preclude the participant's full adherence with or completion of the study.

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Mclean Hospital	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Use	Count of months of opioid use.	12 months
Primary	Engagement in Treatment	Count of months engaged in treatment for opioid use disorder	12 months