Bariatric Surgery CandidateEarly Phase 1SWAPNCT04299373
Surgical Weight Loss and Alcohol Perception
A Early Phase 1 study testing Alcohol: Oral administration and Alcohol: Intravenous administration in people with Bariatric Surgery Candidate, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The study will involve administration of alcohol in a controlled laboratory setting to individuals who are scheduled for Roux-en-Y gastric bypass surgery, and then asking them to return for another laboratory session 3 months following their surgery. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Alcohol: Oral administration and Alcohol: Intravenous administration
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2020to 9 Sep 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Obese, with body weight less than 450 lbs
- non-smoking female volunteers of any race
- age 30-55 years
- drink alcohol in moderation and meet all of the BSC's indications and criteria for RYGB surgery. NIH/NIAAA criteria specify an average of between 3 and 7 standard drinks per week as moderate alcohol drinking (for women). In addition, included participants must fall within the upper or lower tercile of scores on the ASQ for a bariatric population, as determined by the investigator's previous studies with this population.9,10,19
Who cannot join
- their AUDIT scores (16 or above) indicate the possibility of a current or prior alcohol use disorder.
- they report typically drinking less than once per month and consuming less than 3-4 drinks per occasion.
- they are taking prescribed psychoactive medications, other than selective serotonin reuptake inhibitors (SSRIs) for anxiety/depression.
- they are taking medications that might interfere with alcohol metabolism (e.g., anti-histamine h2 receptor antagonists [mainly, antacids used to treat GERD and gastro-intestinal ulcers], certain antibiotics such as erythromycin, or other drugs influencing hepatic cytochrome P450 2E1; see medicine.iupui.edu/clinpharm/ddis/table.aspx).
- their medical records indicate current anemia.
- their FTND scores indicate moderate or greater nicotine dependence (4 or above).
Show all 10Show fewer
- they report they are trying to become pregnant, or produce a positive urine screen for pregnancy at the lab session.
- their body weight is > 450 lbs.
- they have participated in any other research study or medical procedure involving ionizing radiation exposure greater than a chest X-ray in the past 12 months.
- they live more than 60 miles from the CRC.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri Hospital
Columbia, Missouri, 65211
About this study
Official title: Effects of Metabolic Surgery on Alcohol Pharmacokinetics
The study will involve administration of alcohol in a controlled laboratory setting to individuals who are scheduled for Roux-en-Y gastric bypass surgery, and then asking them to return for another laboratory session 3 months following their surgery. A small number will be asked to return again 9 months following their surgery.
The primary objective for this research is to collect pilot data on the effects of metabolic surgery (MS), also known as bariatric surgery, on the metabolism of alcohol. These data will be used as preliminary evidence in support of a subsequent application for funding, to be submitted to the National Institutes of Health.
Read more
A secondary objective for this research is to determine the extent to which MS changes reactivity to alcohol-related cues. Heightened reactivity (e.g., attention bias; craving) to alcohol-related cues is known to signify increased risk for heavy drinking and AUD. No research to date has examined whether the increased sensitivity to alcohol that occurs as a result of MS changes cue-reactivity responses, which in theory reflect an individual's history of learning to associate alcohol consumption with its subjective effects.
An exploratory objective is to compare metabolism of alcohol administered orally versus intravenously. IV infusion of alcohol bypasses so-called "first pass metabolism" of alcohol after absorption by the gastrointestinal tract. Thus, compared to oral ingestion, infusion can achieve the same blood alcohol concentration (BAC) with substantially less total alcohol dosage. Following the hypothesis, this should mean that, compared to oral ingestion, infusion will be associated with less production of liver fat, while also mimicking in pre-surgery patients what the investigators observe with oral ingestion following surgery. This comparison will permit better specification of when (during metabolism) and how alcohol is converted to liver fat, and will allow the investigators to separate effects of initial sensitivity to alcohol (a person's subjective response to the initial introduction of alcohol into the body) from effects associated with tolerance (i.e., the body's attempts to re-establish homeostasis after alcohol is introduced).
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Alcohol: Oral administration, Alcohol: Intravenous administration
- Keywords
- metabolic surgery, alcohol, bariatric surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol: Oral administrationDrug
Patients who plan to undergo bariatric surgery will consume a controlled dose of alcohol orally.
Alcohol: Intravenous administrationDrug
Patients who plan to undergo bariatric surgery will be infused with alcohol intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol: Oral administration | Experimental | Participants in this arm will consume a measured dose of alcohol orally, with the goal of achieving a target peak breath alcohol concentration of .065% within 20 minutes. Receives: Drug: Alcohol: Oral administration |
| Alcohol: Intravenous administration | Experimental | Participants in this arm will be infused intravenously with a dose of alcohol sufficient to raise their breath alcohol concentration to .065% within 20 minutes. Receives: Drug: Alcohol: Intravenous administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Effects of Alcohol Scale
Participants' self-reported feelings of stimulation, sedation, and intoxication following exposure to a controlled dose of alcohol in the lab will be assessed using the Subjective Effects of Alcohol Scale (Morean, Corbin, \& Treat, 2013). Possible score values range from 0 to 140, where a score of 0 indicates the absence of any subjective feelings related to consumed alcohol. This scale and its psychometric properties were first described in the following publication:
Morean ME, Corbin WR, Treat TA. The Subjective Effects of Alcohol Scale: development and psychometric evaluation of a novel assessment tool for measuring subjective response to alcohol. Psychol Assess. 2013;25(3):780-795. doi:10.1037/a0032542
Measured: Multiple intervals following alcohol administration, up to 4 hours post-exposure
Alcohol Urge Questionnaire
Cue-induced craving for alcohol will be assessed using a beverage presentation procedure. Participants complete a self-report measure of craving, the Alcohol Urge Questionnaire. Participants then are presented with a glass containing an alcoholic beverage and are instructed to pick it up and sniff it 5 times over a 3-min period. Then the AUQ is completed again. Change in AUQ score from baseline to the post-alcohol assessment provides a cue-induced craving score. Scores at each assessment can range from 0 to 48, where 0 indicates the total lack of any craving for alcohol.
Bohn, M. J., Krahn, D. D., \& Staehler, B. A. (1995). Development and initial validation of a measure of drinking urges in abstinent alcoholics. Alcoholism: Clinical and Experimental Research,19(3), 600-606.
Measured: Assessed prior to acute alcohol exposure, approximately 10 minutes
Alcohol Sensitivity Questionnaire
Individual differences in self-reported sensitivity to alcohol's effects will be assessed using the Alcohol Sensitivity Questionnaire. This measure contains 15 items, each describing an effect people typically experience when drinking alcohol (e.g., feeling more talkative). For each item, participants indicate (1) whether they have ever experienced the effect in question from drinking alcohol, and (2) if so, the number of standard drinks they typically require in order to experience that effect.
Fleming, K. A., Bartholow, B. D., Hilgard, J., McCarthy, D. M., O'Neill, S. E., Steinley, D., \& Sher, K. J. (2016). The Alcohol Sensitivity Questionnaire: Evidence for construct validity. Alcoholism: Clinical and Experimental Research, 40, 880-888.
Measured: Pre-surgery and 3 months after surgery
Reactivity to alcohol cues: motivational approach bias
The tendency to approach alcohol-related cues will be assessed using a laboratory task known as the Alcohol Approach-Avoidance Task. In this task, images of alcoholic beverages, nonalcoholic beverages, and non-consumable liquids (e.g., motor oil) are presented on a computer monitor one at a time. Participants are instructed to push or pull on a computer joystick in response to each image, depending on whether it appears to be tilted 3 degrees to the right vs. the left. Each type of image is presented in both orientations multiple times. Approach bias is defined for each image type as the difference in response time for images shown in the 'pull' minus the 'push' condition.
Wiers, R.W., Rinck, M., Kordts, R., Houben, K., Strack, F. (2010). Re-training automatic action-tendencies to approach alcohol in hazardous drinkers. Addiction, 105, 279-287.
Measured: Assessed prior to acute alcohol exposure, approximately 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start10 Feb 2020
- Primary completion9 Sep 2022
- Study completion9 Sep 2022
Why it stopped: In an effort to seek a more suitable method to measure alcohol clearance.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of two routes of alcohol administration: (1) oral consumption, or (2) intravenous infusion.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois at Urbana-Champaign
- Responsible party
- Principal investigator, Bruce Bartholow, University of Missouri-Columbia
- Investigators
- Bruce D Bartholow, Ph.D., Principal investigator, University of Missouri-ColumbiaElizabeth J Parks, Ph.D., Principal investigator, University of Missouri-ColumbiaAndrew Wheeler, M.D., Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299373
- Sponsor's protocol ID
- 2016390
- Acronym
- SWAP
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2020
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Metabolic Surgery on Alcohol Pharmacokinetics
- ClinicalTrials.gov ID
- NCT04299373
- Acronym / sponsor ID
- SWAP / 2016390
- Conditions
- Bariatric Surgery Candidate
- Keywords
- metabolic surgery, alcohol, bariatric surgery
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In an effort to seek a more suitable method to measure alcohol clearance.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- University of Illinois at Urbana-Champaign
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 9 Sep 2022 (actual)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will involve administration of alcohol in a controlled laboratory setting to individuals who are scheduled for Roux-en-Y gastric bypass surgery, and then asking them to return for another laboratory session 3 months following their surgery. A small number will be asked to return again 9 months following their surgery.
The primary objective for this research is to collect pilot data on the effects of metabolic surgery (MS), also known as bariatric surgery, on the metabolism of alcohol. These data will be used as preliminary evidence in support of a subsequent application for funding, to be submitted to the National Institutes of Health.
A secondary objective for this research is to determine the extent to which MS changes reactivity to alcohol-related cues. Heightened reactivity (e.g., attention bias; craving) to alcohol-related cues is known to signify increased risk for heavy drinking and AUD. No research to date has examined whether the increased sensitivity to alcohol that occurs as a result of MS changes cue-reactivity responses, which in theory reflect an individual's history of learning to associate alcohol consumption with its subjective effects.
An exploratory objective is to compare metabolism of alcohol administered orally versus intravenously. IV infusion of alcohol bypasses so-called "first pass metabolism" of alcohol after absorption by the gastrointestinal tract. Thus, compared to oral ingestion, infusion can achieve the same blood alcohol concentration (BAC) with substantially less total alcohol dosage. Following the hypothesis, this should mean that, compared to oral ingestion, infusion will be associated with less production of liver fat, while also mimicking in pre-surgery patients what the investigators observe with oral ingestion following surgery. This comparison will permit better specification of when (during metabolism) and how alcohol is converted to liver fat, and will allow the investigators to separate effects of initial sensitivity to alcohol (a person's subjective response to the initial introduction of alcohol into the body) from effects associated with tolerance (i.e., the body's attempts to re-establish homeostasis after alcohol is introduced).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two routes of alcohol administration: (1) oral consumption, or (2) intravenous infusion.
| Arm | Type | Receives |
|---|---|---|
| Alcohol: Oral administration | Experimental | Drug: Alcohol: Oral administrationParticipants in this arm will consume a measured dose of alcohol orally, with the goal of achieving a target peak breath alcohol concentration of .065% within 20 minutes. |
| Alcohol: Intravenous administration | Experimental | Drug: Alcohol: Intravenous administrationParticipants in this arm will be infused intravenously with a dose of alcohol sufficient to raise their breath alcohol concentration to .065% within 20 minutes. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Obese, with body weight less than 450 lbs
- non-smoking female volunteers of any race
- age 30-55 years
- drink alcohol in moderation and meet all of the BSC's indications and criteria for RYGB surgery. NIH/NIAAA criteria specify an average of between 3 and 7 standard drinks per week as moderate alcohol drinking (for women). In addition, included participants must fall within the upper or lower tercile of scores on the ASQ for a bariatric population, as determined by the investigator's previous studies with this population.9,10,19
Key exclusion criteria (10 listed)
- their AUDIT scores (16 or above) indicate the possibility of a current or prior alcohol use disorder.
- they report typically drinking less than once per month and consuming less than 3-4 drinks per occasion.
- they are taking prescribed psychoactive medications, other than selective serotonin reuptake inhibitors (SSRIs) for anxiety/depression.
- they are taking medications that might interfere with alcohol metabolism (e.g., anti-histamine h2 receptor antagonists [mainly, antacids used to treat GERD and gastro-intestinal ulcers], certain antibiotics such as erythromycin, or other drugs influencing hepatic cytochrome P450 2E1; see medicine.iupui.edu/clinpharm/ddis/table.aspx).
- their medical records indicate current anemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol: Oral administrationPatients who plan to undergo bariatric surgery will consume a controlled dose of alcohol orally. | Drug | Alcohol: Oral administration |
| Alcohol: Intravenous administrationPatients who plan to undergo bariatric surgery will be infused with alcohol intravenously. | Drug | Alcohol: Intravenous administration |
Primary outcome
Subjective Effects of Alcohol Scale
Time frame: Multiple intervals following alcohol administration, up to 4 hours post-exposure
Participants' self-reported feelings of stimulation, sedation, and intoxication following exposure to a controlled dose of alcohol in the lab will be assessed using the Subjective Effects of Alcohol Scale (Morean, Corbin, \& Treat, 2013). Possible score values range from 0 to 140, where a score of 0 indicates the absence of any subjective feelings related to consumed alcohol. This scale and its psychometric properties were first described in the following publication: Morean ME, Corbin WR, Treat TA. The Subjective Effects of Alcohol Scale: development and psychometric evaluation of a novel assessment tool for measuring subjective response to alcohol. Psychol Assess. 2013;25(3):780-795. doi:10.1037/a0032542
Alcohol Urge Questionnaire
Time frame: Assessed prior to acute alcohol exposure, approximately 10 minutes
Cue-induced craving for alcohol will be assessed using a beverage presentation procedure. Participants complete a self-report measure of craving, the Alcohol Urge Questionnaire. Participants then are presented with a glass containing an alcoholic beverage and are instructed to pick it up and sniff it 5 times over a 3-min period. Then the AUQ is completed again. Change in AUQ score from baseline to the post-alcohol assessment provides a cue-induced craving score. Scores at each assessment can range from 0 to 48, where 0 indicates the total lack of any craving for alcohol. Bohn, M. J., Krahn, D. D., \& Staehler, B. A. (1995). Development and initial validation of a measure of drinking urges in abstinent alcoholics. Alcoholism: Clinical and Experimental Research,19(3), 600-606.
Alcohol Sensitivity Questionnaire
Time frame: Pre-surgery and 3 months after surgery
Individual differences in self-reported sensitivity to alcohol's effects will be assessed using the Alcohol Sensitivity Questionnaire. This measure contains 15 items, each describing an effect people typically experience when drinking alcohol (e.g., feeling more talkative). For each item, participants indicate (1) whether they have ever experienced the effect in question from drinking alcohol, and (2) if so, the number of standard drinks they typically require in order to experience that effect. Fleming, K. A., Bartholow, B. D., Hilgard, J., McCarthy, D. M., O'Neill, S. E., Steinley, D., \& Sher, K. J. (2016). The Alcohol Sensitivity Questionnaire: Evidence for construct validity. Alcoholism: Clinical and Experimental Research, 40, 880-888.
Reactivity to alcohol cues: motivational approach bias
Time frame: Assessed prior to acute alcohol exposure, approximately 10 minutes
The tendency to approach alcohol-related cues will be assessed using a laboratory task known as the Alcohol Approach-Avoidance Task. In this task, images of alcoholic beverages, nonalcoholic beverages, and non-consumable liquids (e.g., motor oil) are presented on a computer monitor one at a time. Participants are instructed to push or pull on a computer joystick in response to each image, depending on whether it appears to be tilted 3 degrees to the right vs. the left. Each type of image is presented in both orientations multiple times. Approach bias is defined for each image type as the difference in response time for images shown in the 'pull' minus the 'push' condition. Wiers, R.W., Rinck, M., Kordts, R., Houben, K., Strack, F. (2010). Re-training automatic action-tendencies to approach alcohol in hazardous drinkers. Addiction, 105, 279-287.
Results and safety
The study was stopped early (reason given: In an effort to seek a more suitable method to measure alcohol clearance.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Bariatric Surgery Candidate
Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
Active, not recruiting
Stepwise PEEP vs Sustained Inflation in Bariatric Surgery Patients
Recruitment, Bariatric Surgery Candidate
RecruitingObservational study
Blood Collection Biorepository for Liver Disease Research
Non-Alcoholic Steatohepatitis(NASH), Hepatitis C
Enrolling by invitationObservational study
Dietary Sugar Absorptive Phenotype for Prediction of Weight Loss Outcome
Obese, Healthy
Active, not recruiting
Evaluation of the Stress Response in Bariatric Surgery With and Without the Use of Opioids
Opioid Use, Unspecified, Bariatric Surgery Candidate
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce D Bartholow, Ph.D. principal investigator
University of Missouri-Columbia
Elizabeth J Parks, Ph.D. principal investigator
University of Missouri-Columbia
Andrew Wheeler, M.D. principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Alcohol: Oral administration and Alcohol: Intravenous administration in people with Bariatric Surgery Candidate, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: In an effort to seek a more suitable method to measure alcohol clearance.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Effects of Alcohol Scale (time frame: Multiple intervals following alcohol administration, up to 4 hours post-exposure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.