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Roux en Y Gastric Bypass for Bariatric Surgery Candidates

N/A

Waitlist Available

Led By Kristine Steffen, PharmD, PhD

Research Sponsored by Neuropsychiatric Research Institute, Fargo, North Dakota

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 pre-surgery (up to 3 months before surgery) and 1 year post surgery

Awards & highlights

No Placebo-Only Group

Summary

The proposed project will help to understand the changes in reinforcement and impairment experienced by Roux en Y bariatric surgery (RYGB) patients who consume alcohol. In this study the investigators propose to investigate RYGB patients with a prospective, longitudinal design. Investigators will examine driving impairment before and after surgery as well as study cognitive changes and reinforcement changes that may occur in RYGB patients while consuming alcohol. Finally, investigators aim to better characterize the changes that occur in the pharmacokinetics of alcohol following bariatric surgery and examine key variables which may play a role in the development in alcohol use disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-surgery (up to 3 months before surgery) and 1 year post surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-surgery (up to 3 months before surgery) and 1 year post surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-surgery (up to 3 months before surgery) and 1 year post surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Drive Safety RS-300 Research Driving Simulator Performance

Secondary study objectives

Change in 2-Back task

Change in Desire-for-Drug Scale

Change in pharmacokinetics as measured via blood alcohol concentrations

Other study objectives

Change in Addiction Severity Index (ASI)

Change in Adult Temperament Questionnaire-Short Form (ATQ-SF; Evans & Rothbart, 2007)

Change in Alcohol Use Disorders Identification Test (AUDIT; Barbor, et al., 2001)

+9 more

Side effects data

From 2017 Phase 2 trial • 17 Patients • NCT01779024

59%

Increased Appetite

41%

Somnolence

35%

Euphoric mood

29%

Fatigue

12%

Hyperhidrosis

12%

Memory impairment

12%

Dizziness

12%

Nausea

Feeling hot

Flushing

Headache

Decreased appetite

100%

80%

60%

40%

20%

Study treatment Arm

Ghrelin

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Roux en Y Gastric BypassExperimental Treatment1 Intervention

Participants recruited for this protocol will be those planning to undergo Roux-en-Y Gastric Bypass (RYGB). Upon study screening completion, participants will take part in a total of 4 laboratory assessment days where a fixed dose of alcohol will be given. * 2 pre-surgery research appointments where participants will be given alcohol: a driving simulator day and a cognitive testing and reinforcement testing day. * 2 post-surgery (1 year) research appointments where you will be given alcohol: a driving simulator day and a cognitive testing and reinforcement testing day.

Do I qualify?Apply below to find out