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Alcohol for Alcoholism (BED IN 36 Trial)

Phase 1
Waitlist Available
Led By Craig Rush, PhD
Research Sponsored by Craig Rush
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 sessions over approximately 4 weeks of study participation
Awards & highlights

BED IN 36 Trial Summary

This trial will study the effects of alcohol while taking placebo, duloxetine, methylphenidate, and a combination of duloxetine and methylphenidate.

Eligible Conditions
  • Alcoholism

BED IN 36 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after at least six days of placebo, duloxetine or methylphenidate maintenance
This trial's timeline: 3 weeks for screening, Varies for treatment, and after at least six days of placebo, duloxetine or methylphenidate maintenance for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reinforcing Effects
Secondary outcome measures
Breath Alcohol Level
Diastolic blood pressure
Heart rate
+2 more

Side effects data

From 2017 Phase 2 trial • 17 Patients • NCT01779024
59%
Increased Appetite
41%
Somnolence
35%
Euphoric mood
29%
Fatigue
12%
Memory impairment
12%
Hyperhidrosis
12%
Dizziness
12%
Nausea
6%
Feeling hot
6%
Flushing
6%
Headache
6%
Decreased appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ghrelin
Placebo

BED IN 36 Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low Dose DuloxetineExperimental Treatment3 Interventions
Subjects will receive 30 mg oral duloxetine one time daily.
Group II: High Dose DuloxetineExperimental Treatment3 Interventions
Subjects will receive 60 mg oral duloxetine one time daily.
Group III: PlaceboPlacebo Group3 Interventions
Subjects will receive oral placebo capsules one time daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylphenidate
2014
Completed Phase 4
~431850
Alcohol
2008
Completed Phase 3
~2000
Duloxetine
2011
Completed Phase 4
~4170

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Craig RushLead Sponsor
5 Previous Clinical Trials
536 Total Patients Enrolled
1 Trials studying Alcoholism
444 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
800 Previous Clinical Trials
1,362,978 Total Patients Enrolled
423 Trials studying Alcoholism
985,689 Patients Enrolled for Alcoholism
Craig Rush, PhDPrincipal Investigator - University of Kentucky
Commonwealth Regional Specialty Hospital, Medical Center, The
Rush Medical College Of Rush University (Medical School)
Franciscan Medical Ctr-Dayton (Residency)
1 Previous Clinical Trials
40 Total Patients Enrolled

Frequently Asked Questions

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

Does the study encompass participants of any age, including those over 55?

"This clinical trial is only open to those aged between 21 and 55. Participants outside of this age range can, however, consider applying for the 50 trials that are available to under-18s or the 286 studies designed for over 65s."

Answered by AI

Does the Food and Drug Administration sanction alcohol?

"The safety of alcohol is still largely unknown, so it has been assigned a rating of 1. This assessment reflects the fact that this trial is only at Phase 1 and there are limited clinical data points to support both efficacy and safety."

Answered by AI

What is the total participant count of this investigation?

"Affirmative. Data found on clinicaltrials.gov verifies that this trial is actively accepting participants, which started being posted on September 1st 2018 and was last updated on the 23rd of September 2022. In total 48 patients between one location can partake in the experiment."

Answered by AI

Are there any opportunities for participants to join this clinical experiment?

"Indeed, the information posted on clinicaltrials.gov points towards this medical trial being open for recruitment. Initially posted on September 1st 2018 and recently updated on September 23rd 2022, it seeks to recruit 48 participants from a single location."

Answered by AI

To what extent is enrollment for this trial open?

"This clinical trial is recruiting 48 individuals aged 21 to 55 with a diagnosis of alcoholism. For eligibility, potential participants must also possess the following characteristics: BMI between 19-35; not receiving treatment prior to enrollment; one episode of binge drinking in last 30 days (accordingly 5+ and 4+ drinks for males/females); females using reliable birth control method, who are non-pregnant and not lactating; judged psychiatrically and physically healthy by medical staff; able to abstain from alcohol for 12 hours before sessions begin."

Answered by AI

What medicinal benefits are typically associated with Alcohol consumption?

"Alcohol can be an effective treatment for obstructive hypertrophic cardiomyopathy, ethylene glycol poisoning, and Attention Deficit Hyperactivity Disorder (ADHD)."

Answered by AI
~3 spots leftby Apr 2025