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Behavioral Intervention

Intervention arm for Social Stigma

Led By Adams L Sibley, MPH
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 18 and older at enrollment
Be older than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up from first enrollment visit to study completion date (up to 8 weeks)
Awards & highlights

Study Summary

This trial, Project RESTART, is testing a 4-week text message program to help people who use drugs deal with self-stigma. Participants will receive two text messages daily for four weeks, focusing

Who is the study for?
This trial is for individuals who use drugs and are experiencing self-stigma. Participants will receive daily text messages aimed at helping them resist stigma, empower themselves, maintain recovery, and develop a positive identity beyond substance use.Check my eligibility
What is being tested?
The RESTART program sends two daily texts over four weeks to help people using drugs combat self-stigma. This pilot study tests if the approach is workable and well-received by participants, with a focus on changes in their feelings of stigma.See study design
What are the potential side effects?
Since this intervention involves receiving text messages rather than medication or medical procedures, there are no direct physical side effects. However, emotional discomfort may arise as participants reflect on personal experiences related to stigma.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am 18 years old or older.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first enrollment visit to study completion date (up to 8 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first enrollment visit to study completion date (up to 8 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Stigma Resistance Scale (SRS) Score
Change in Substance Abuse Self-Stigma Scale (SASSS) Score
Percentage of Participants Retained in Study (Feasibility - Retention)
+9 more
Secondary outcome measures
Change in Adult Dispositional Hope Scale Score
Change in Rosenberg Self-Esteem Scale Score

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intervention armExperimental Treatment1 Intervention
Participants in the intervention arm will receive 56 text messages over 4-weeks.

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,504 Previous Clinical Trials
4,187,632 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,563 Total Patients Enrolled
Adams L Sibley, MPHPrincipal InvestigatorDoctoral Candidate

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently eligible to enroll in this research study?

"Referring to the details on clinicaltrials.gov, it appears that recruitment for this particular research project has concluded. Originally shared on March 4th, 2024 and most recently updated on February 20th, 2024. However, there are numerous other studies actively seeking participants, with a total of 366 ongoing trials available for enrollment currently."

Answered by AI
~0 spots leftby Apr 2024