Addiction Remission and Addiction Transfer After Bariatric Surgery

Obesity Clinical Trial

Official title:

Addiction Remission and Addiction Transfer After Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02757716
• Other study ID #: FF 146/2015
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: January 2019

Study information

• Verified date: May 2019
• Source: Sana Klinikum Offenbach
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate addiction remission and addiction transfer after bariatric surgery.

Description:

A prospective study to evaluate addiction remission and addiction transfer 6 and 24 months after primary surgery (sleeve gastrectomy, Roux-en-Y- gastric bypass and One anastomosis gastric bypass) in obese patients. A questionnaire evaluating food addiction (Yale Food Scale), alcohol addiction (Audit Scale), nicotine addiction (Fagerström Scale), exercise addiction (Exercise Addiction Inventory), internet addiction (ISS20) and drug addiction (Drug Use Questionnaire) gets completed prior to surgery and 6 and 24 months after surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• BMI > 35kg/m² and obesity related disease or BMI > 40kg/m²

Exclusion Criteria:

• decline of study participation

Related Conditions & MeSH terms

• Behavior, Addictive
• Obesity

Intervention

Other:
• Questionnaire
Every patient who undergo surgery will fill out a questionnaire containing validated scales concerning food, alcohol, nicotine, internet and exercise and drug addiction prior, 6 months and 24 months after surgery.

Locations

Country	Name	City	State
Germany	Sana Klinikum Offenbach	Offenbach	Offenbach Am Main

Sponsors (1)

Lead Sponsor	Collaborator
Sana Klinikum Offenbach

Country where clinical trial is conducted

Germany, 

References & Publications (5)

Cuellar-Barboza AB, Frye MA, Grothe K, Prieto ML, Schneekloth TD, Loukianova LL, Hall-Flavin DK, Clark MM, Karpyak VM, Miller JD, Abulseoud OA. Change in consumption patterns for treatment-seeking patients with alcohol use disorder post-bariatric surgery. — View Citation

Fowler L, Ivezaj V, Saules KK. Problematic intake of high-sugar/low-fat and high glycemic index foods by bariatric patients is associated with development of post-surgical new onset substance use disorders. Eat Behav. 2014 Aug;15(3):505-8. doi: 10.1016/j. — View Citation

Ivezaj V, Saules KK, Wiedemann AA. "I didn't see this coming.": why are postbariatric patients in substance abuse treatment? Patients' perceptions of etiology and future recommendations. Obes Surg. 2012 Aug;22(8):1308-14. doi: 10.1007/s11695-012-0668-2. — View Citation

Pepino MY, Stein RI, Eagon JC, Klein S. Bariatric surgery-induced weight loss causes remission of food addiction in extreme obesity. Obesity (Silver Spring). 2014 Aug;22(8):1792-8. doi: 10.1002/oby.20797. Epub 2014 May 23. — View Citation

Volkow ND, Wang GJ, Tomasi D, Baler RD. The addictive dimensionality of obesity. Biol Psychiatry. 2013 May 1;73(9):811-8. doi: 10.1016/j.biopsych.2012.12.020. Epub 2013 Jan 29. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Addiction remission	Addiction remission (evaluated by questionnaire) after obesity surgery	24 months after surgery
Secondary	Addiction transfer	Addiction transfer (evaluated by questionnaire) after obesity surgery	24 months after surgery
Secondary	Excess Weight Loss (EWL in %)	EWL 24 months after surgery measured as a physiological parameter at 2 year Follow-Up	24 months after surgery