Gut Health and the Effect on Substance and Alcohol Cravings

Craving Clinical Trial

Official title:

Gut Health and the Effect on Substance and Alcohol Cravings

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06026982
• Other study ID #: #23-MCCA-101
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: September 2023
• Est. completion date: October 2023

Study information

• Verified date: September 2023
• Source: City Rescue Mission Medical Clinic
• Contact: Anna M McCarthy, MD, MPH
• Phone: 9049554247
• Email: annamarie5092[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Gut health has been linked with improvement in mental health but no research has been done to evaluate if improving gut health can have an effect on alcohol and substance cravings. This pilot study is to evaluate if any decrease in cravings can be found with probiotics/prebiotics by improving gut health. Participants will take a pre-survey to evaluate their cravings. Participants will then be started on a regimen of probiotic and prebiotic with a pickle daily for 30 days to improve gut health. Then participants will take the same survey to evaluate if there has been any decrease in cravings.

Description:

Consent and a pre survey on cravings will be collected. Then participants will take a probiotic/prebiotic and a pickle for 30 days. Participants will be given a probiotic formula by Rugby Health that has Bacillus Coagulans spores 1billion colony forming unit and inulin 250mg along with a pickle daily for 30 days. After 30 days the same survey will be taken by the participants and a paired t test will be used to analyze if there is a statistical change in cravings. Participants will be in a recovery program with a prior history of substance or alcohol abuse and will be abstaining from drugs and alcohol.

The purpose of the study is to evaluate if improving gut health by the above intervention can also decrease substance and alcohol cravings. Probiotics and prebiotics have been shown to improve mental health with a decrease in depression and PTSD but no studies have investigated if improving gut health can decrease substance or alcohol cravings. Probiotics are a cheap intervention that many recovery centers with limited recourses would be able to use. Fermented foods like pickles have been shown to have significant benefit to gut health with improvement in the gut biome. Pickles are also affordable which is why this combination was chosen to be studied.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Males and females age 18-75 years old

• current cravings for substance or alcohol use

• enrolled in a recovery clinic

• able to understand and comply with the requirements of the study

• provision of written informed consent.

Exclusion Criteria:

• Any alcohol or substance use in the past week

• any narcotic use (including methadone and buprenorphine)

• daily probiotic product use in the last 2 weeks

• women who are pregnant or planning to become pregnant during the trial

• if they already have no alcohol or substance cravings

• non English speakers.

Related Conditions & MeSH terms

• Craving

Intervention

Dietary Supplement:
• probiotic and pickle
probiotic formula by Rugby Health that has Bacillus Coagulans spores 1billion CFU and inulin 250mg along with a pickle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
City Rescue Mission Medical Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in substance or alcohol cravings	Evaluation via the same survey before and after probiotic and a pickle for 30 days to see if there is any change in cravings.; A pre and post survey will be administered with cravings rated with a scale of 1-5, no cravings would be the number one to extreme cravings with a number of 5. A paired t-test will then be used to analyze the data.	30 days