FORWARD: Following Outcomes Remotely Within Addiction Recovery Domains

Sponsor

Mclean Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06001437

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

1,600

Enrollment

45.5

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Use Disorder

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

CTN-0126 Following Outcomes Remotely Within Addiction Recovery Domains

Anticipated Study Start Date :

Sep 15, 2023

Anticipated Primary Completion Date :

Jul 1, 2027

Anticipated Study Completion Date :

Jul 1, 2027

Outcome Measures

Primary Outcome Measures

Opioid Use [12 months]
Count of months of opioid use.
Engagement in Treatment [12 months]
Count of months engaged in treatment for opioid use disorder

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

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.
Be willing and able to provide locator information for survey distribution (mobile number and/or email address).
Be willing to allow the linkage of prior clinical trial study data to the current study record.

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Mclean Hospital
National Institute on Drug Abuse (NIDA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

McHugh, R. Kathryn, Associate Professor, Mclean Hospital

ClinicalTrials.gov Identifier:

NCT06001437

Other Study ID Numbers:

2023P000766
3UG1DA015831-21S4

First Posted:

Aug 21, 2023

Last Update Posted:

Aug 22, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Opioid-Related Disorders

Study Results

No Results Posted as of Aug 22, 2023