Intravenous Alcohol for Alcoholism

Overseen By Jessica Jenkins, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, Los Angeles

Must not be taking: Antidepressants, Anticonvulsants, Opioids, Benzodiazepines

Disqualifiers: Substance use disorder, Schizophrenia, Bipolar, Suicidal ideation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

210 Participants Needed

Trial Summary

Do I need to stop taking my current medications to join the trial?

Yes, you must stop taking any medications known to interact with alcohol, such as antidepressants, anticonvulsants, opioids, benzodiazepines, medications for diabetes, and medications that affect alcohol metabolism.

What data supports the idea that Intravenous Alcohol for Alcoholism is an effective treatment?

The available research does not provide any data supporting the effectiveness of Intravenous Alcohol for Alcoholism. The studies mentioned focus on other intravenous treatments for different conditions, such as proton pump inhibitors for stomach acidity and albumin for critically ill patients. None of these studies address the use of Intravenous Alcohol for treating alcoholism. ^{1 2 3 4 5}

What safety data exists for intravenous alcohol treatment?

The safety data for intravenous alcohol treatment is limited and suggests potential concerns. Studies indicate that intravenous ethanol has a questionable efficacy, inconsistent pharmacokinetic profile, and a narrow therapeutic index, making its routine use not recommended, especially in critically ill patients. Research has not shown compelling evidence of adverse effects from ethanol administration in research settings, but clinical concerns such as inconsistent administration and lack of monitoring have been noted. Ethanol's toxic effects are dose-dependent, with a proposed acceptable daily intake of 7 g per day. ^{6 7 8 9 10}

Is Intravenous Alcohol a promising drug for treating alcoholism?

The provided research articles do not discuss the use of Intravenous Alcohol as a treatment for alcoholism. They focus on other intravenous drugs and safety measures, so there is no information to suggest that Intravenous Alcohol is a promising treatment for alcoholism. ^{1 2 11 12 13}

What is the purpose of this trial?

The goal of this translational study is to understand different reasons why people between the ages of 21 and 65 with alcohol use disorder are motivated to self-administer alcohol. The main questions it aims to answer are: * How does a person's desire for a reward affect their motivation to self-administer alcohol? * How does a person's emotions affect their motivation to self-administer alcohol? * How does a person's cognitive functioning affect their motivation to self-administer alcohol? Participants will be asked to complete questionnaires about their mood, habits, and functioning and will complete an IV alcohol administration that will include pressing a button to receive additional doses of IV alcohol.

Eligibility Criteria

This trial is for individuals aged 21 to 65 who struggle with alcohol use disorder. It aims to understand their motivations for drinking by examining the influence of reward desire, emotions, and cognitive functioning on their choice to self-administer alcohol.

Inclusion Criteria

Participants must meet current DSM-5 diagnostic criteria for alcohol use disorder mild-to-severe

Participants must have self-reported alcohol use in the past 30 days

I am between 21 and 65 years old.

Exclusion Criteria

Participants must not currently be treatment seeking, in treatment for alcohol use, or have a history of treatment in the 30 days prior to consent

Participants must not have a current DSM-5 diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine

Participants must not have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any other psychotic disorder

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Alcohol Challenge

Participants undergo an intravenous alcohol administration to reach a target BrAC of 0.06 g/dl, followed by assessments of craving, mood, and control over drinking

10 hours

1 visit (in-person)

Progressive Ratio Self-Administration

Participants engage in a self-administration paradigm where they press a button to receive additional doses of IV alcohol, with assessments of incentive salience, negative emotionality, and executive dysfunction

10 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the alcohol administration and self-administration phases

4 weeks

Treatment Details

Interventions

• Intravenous Alcohol

Trial Overview The study tests how different factors motivate people with alcoholism to self-administer intravenous (IV) alcohol. Participants will answer questionnaires and engage in an IV alcohol administration task where they can press a button for more doses.

Participant Groups

Group I: Intravenous Alcohol Experimental Treatment 1 Intervention

Participants will receive 6% ethanol v/v in saline administered intravenously through the physiologically based pharmacokinetic model implemented in the Computerized Alcohol Infusion System.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Findings from Research

In a study involving healthy adults, IV esomeprazole (40 mg) was found to maintain intragastric pH above 4.0 significantly longer than IV lansoprazole (30 mg) over a 5-day period, indicating better control of stomach acidity.

Esomeprazole also achieved stable pH levels faster than lansoprazole, suggesting it may be a more effective option for patients needing intravenous proton pump inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous esomeprazole 40 mg vs. intravenous lansoprazole 30 mg for controlling intragastric acidity in healthy adults. Pisegna, JR., Sostek, MB., Monyak, JT., et al.[2022]

A study comparing intravenous push (IVP) and intravenous piggyback (IVPB) administration of levetiracetam found that IVP had a similar incidence of adverse events like bradycardia and hypotension, suggesting it is a safe alternative for doses up to 4000 mg.

IVP administration significantly reduced the time to first-dose delivery (23.5 minutes vs. 55 minutes for IVPB), indicating improved efficiency in medication delivery without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Intravenous Push Levetiracetam Compared to Intravenous Piggyback at a Tertiary Academic Medical Center: A Retrospective Analysis. Alkazemi, A., McLaughlin, KC., Chan, MG., et al.[2022]

Intravenous albumin does not improve outcomes in most critically ill patients, based on a review of experimental data.

The study discusses the metabolism and kinetics of albumin, highlighting its importance in critically ill patients, but ultimately concludes that its use may not be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of intravenous albumin in the critically ill patient. Guthrie, RD., Hines, C.[2005]

In a study of 2825 patients across 61 ICUs in Australia and New Zealand, the use of crystalloid fluids for resuscitation significantly increased from 28.9% in 2007 to 50.5% in 2013, indicating a shift towards these fluids in critical care.

The use of colloid fluids decreased notably during the same period, particularly gelatin-based colloids, which dropped from 28.9% to just 2.1%, suggesting a change in preference towards buffered salt solutions for better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resuscitation fluid use in Australian and New Zealand Intensive Care Units between 2007 and 2013. Hammond, NE., Taylor, C., Saxena, M., et al.[2018]

In a study of 160 patients with high-risk peptic ulcers, those treated with oral omeprazole experienced a significantly shorter hospital stay (mean 62.8 hours) compared to the placebo group (mean 75 hours), indicating improved recovery times.

Patients receiving oral omeprazole also had a lower re-bleeding rate (12% vs. 26%) and required fewer blood transfusions (1.13 bags vs. 1.68 bags), demonstrating its efficacy in managing complications associated with high-risk ulcer bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of oral omeprazole in reducing re-bleeding in bleeding peptic ulcers: a prospective, double-blind, randomized, clinical trial. Kaviani, MJ., Hashemi, MR., Kazemifar, AR., et al.[2019]

Critically ill patients with alcoholism face higher risks of complications from alcohol withdrawal syndrome, and while benzodiazepines are the standard treatment, intravenous ethanol has been suggested as an alternative.

However, due to a lack of strong clinical trials and concerns about its effectiveness and safety, routine use of intravenous ethanol for treating alcohol withdrawal in critically ill patients is not recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous ethanol for the treatment of alcohol withdrawal syndrome in critically ill patients. Hodges, B., Mazur, JE.[2013]

Ethanol has therapeutic benefits in various medical applications, including as an antidote for methanol and ethylene glycol poisoning, treatment for alcohol withdrawal syndrome, and as an antiseptic, with a generally positive risk-benefit ratio.

Recent advancements in medical technology have expanded ethanol's use as a precise embolization, sclerosing, or ablation agent, highlighting its effectiveness and safety in these new therapeutic roles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Applications of Ethanol: A Review. Le Daré, B., Gicquel, T.[2020]

Research on ethanol administration has provided valuable insights into the mechanisms of alcohol dependence and has improved treatment understanding, with no compelling evidence of adverse effects on participants with alcohol dependence.

An ethical review process is recommended for ethanol administration studies, focusing on respect, beneficence, and justice, and tailoring risk/benefit analyses based on the specific backgrounds of different groups of alcoholic subjects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethical, scientific and clinical issues in ethanol administration research involving alcoholics as human subjects. Dolinsky, ZS., Babor, TF.[2013]

In a study of 68 patients receiving intravenous ethanol (IVE) for alcohol withdrawal, 67.6% were admitted for alcohol-related trauma, highlighting the need for effective management in this population.

The study revealed serious clinical concerns, including inconsistent administration of IVE and a low referral rate to alcohol consult teams, suggesting a need for improved guidelines to enhance patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of intravenous ethanol in hospitalized patients. DiPaula, B., Tommasello, A., Solounias, B., et al.[2019]

The study estimates that the toxic range of ethanol consumption is between 35-200 grams per day, highlighting the potential risks associated with high alcohol intake.

Based on their analysis, the researchers propose an acceptable daily intake (ADI) for ethanol of only 7 grams per day, suggesting that even moderate consumption should be approached with caution for long-term health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The toxicity of ethanol. A tentative risk evaluation. Rydberg, U., Skerfving, S.[2019]

A study involving 744 cardiac surgery patients assessed the effectiveness of smart infusion pumps with decision support software, but found no significant reduction in serious medication error rates during their use, indicating that errors remain a concern in intravenous medication administration.

Despite the potential benefits of smart pumps, issues such as non-compliance with drug libraries and lack of documentation of physician orders hindered their effectiveness, suggesting that both technology and nursing practices need improvement to enhance medication safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled trial of smart infusion pumps to improve medication safety in critically ill patients. Rothschild, JM., Keohane, CA., Cook, EF., et al.[2019]

The study evaluated three methods of administering hydroxocobalamin in emergency care for children, finding that directly extracting the required volume from the vial and infusing it (Mode 3) was the fastest, most precise, and easiest method among the options tested.

Mode 3 not only allowed for accurate dosing but also proved to be the most economical, making it the recommended approach for administering hydroxocobalamin in pediatric emergency situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimization of intravenous administration of hydroxocobalamin in pediatric emergencies - HYDROX-OPTIMIS study. Christel, H., Aubry, SC., Florence, T., et al.[2023]

Erroneous intravenous drug administration can lead to serious patient harm and significant financial costs, highlighting the need for improved safety measures in hospitals.

The proposed VEINROM system aims to categorize and streamline the administration of critical drugs, potentially reducing the risk of errors in anesthesiology and improving patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

VEINROM: A possible solution for erroneous intravenous drug administration. Tewari, A., Palm, B., Hines, T., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Intravenous esomeprazole 40 mg vs. intravenous lansoprazole 30 mg for controlling intragastric acidity in healthy adults. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Safety of Intravenous Push Levetiracetam Compared to Intravenous Piggyback at a Tertiary Academic Medical Center: A Retrospective Analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Use of intravenous albumin in the critically ill patient. [2005]

4. United States pubmed.ncbi.nlm.nih.gov

Resuscitation fluid use in Australian and New Zealand Intensive Care Units between 2007 and 2013. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Effect of oral omeprazole in reducing re-bleeding in bleeding peptic ulcers: a prospective, double-blind, randomized, clinical trial. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Intravenous ethanol for the treatment of alcohol withdrawal syndrome in critically ill patients. [2013]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Therapeutic Applications of Ethanol: A Review. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Ethical, scientific and clinical issues in ethanol administration research involving alcoholics as human subjects. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

An evaluation of intravenous ethanol in hospitalized patients. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

The toxicity of ethanol. A tentative risk evaluation. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

A controlled trial of smart infusion pumps to improve medication safety in critically ill patients. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Optimization of intravenous administration of hydroxocobalamin in pediatric emergencies - HYDROX-OPTIMIS study. [2023]

13. India pubmed.ncbi.nlm.nih.gov

VEINROM: A possible solution for erroneous intravenous drug administration. [2021]