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Technology-Supported Intervention for Alcohol Use Disorder (Wisepill+SMS Trial)
N/A
Waitlist Available
Research Sponsored by Butler Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Wisepill+SMS Trial Summary
This trial is testing a new way to help people with alcohol use disorders who are taking disulfiram, by using a device that tracks if they take their doses and sends reminder texts.
Who is the study for?
This trial is for adults aged 18-65 with Alcohol Use Disorder (AUD) who are prescribed disulfiram and enrolled in an Alcohol and Drug Partial Hospital Program. Participants must have a phone capable of receiving SMS, email access, and meet AUD criteria per the SCID-P assessment. Those with severe substance use disorders, suicidal or homicidal tendencies, psychotic conditions, or using other alcohol treatment meds besides disulfiram cannot join.Check my eligibility
What is being tested?
The study tests a new intervention combining Wisepill—a device that monitors medication taking—with tailored SMS messages to support adherence to disulfiram treatment for AUD. The trial compares three groups: Wisepill+SMS reminders/supports; Wisepill-only; and standard care without these technologies over a period of 12 weeks.See study design
What are the potential side effects?
While this trial focuses on technology-based interventions rather than medications, participants may still experience side effects from their ongoing disulfiram treatment if they consume alcohol which can include nausea, headache, vomiting, chest pain among others.
Wisepill+SMS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Alcohol breath analysis
PEth blood alcohol testing
Self-reported medication adherence
+3 moreSecondary outcome measures
Alcohol Abstinence Self-Efficacy Scale
Brief COPE
Multidimensional Scale of Perceived Social Support
Wisepill+SMS Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Wisepill+SMSExperimental Treatment1 Intervention
Group II: Disulfiram-onlyActive Control1 Intervention
Group III: Wisepill-onlyActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Butler HospitalLead Sponsor
129 Previous Clinical Trials
16,343 Total Patients Enrolled
4 Trials studying Alcoholism
414 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
798 Previous Clinical Trials
1,361,506 Total Patients Enrolled
422 Trials studying Alcoholism
985,133 Patients Enrolled for Alcoholism
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently experiencing thoughts of harming yourself or others.You have been diagnosed with Alcohol Use Disorder (AUD) by using a specific assessment called SCID-P based on the DSM-5 guidelines.You have a history of a mental condition called psychosis, or you currently experience symptoms like hallucinations or delusions.You are currently taking medication to treat alcohol addiction, except for disulfiram.
Research Study Groups:
This trial has the following groups:- Group 1: Disulfiram-only
- Group 2: Wisepill+SMS
- Group 3: Wisepill-only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings to become involved in this experiment at present?
"Clinicaltrials.gov displays that this trial is accepting nominations at the time of writing; with its inception on November 29th 2018 and most recent update occurring on August 10th 2022."
Answered by AI
How many individuals have signed up to participate in this research?
"Affirmative. The information on clinicaltrials.gov indicates that this experiment is currently soliciting participants - it was originally posted on November 29th 2018 and last updated on August 10th 2022. They are seeking 75 people to join their research from one medical facility."
Answered by AI
Is this medical trial available to participants under the age of sixty?
"This research project is inviting participants who are of legal age and younger than 65 years old."
Answered by AI
Can I qualify to join this clinical investigation?
"This research project is searching for 75 participants aged 18-65 who consume alcohol. The eligibility criteria also stipulate a requirement of access to an SMS enabled cell phone and email account."
Answered by AI
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