What side effects are associated with this type of intervention?

Common treatments for alcoholism include medications like naltrexone, acamprosate, and disulfiram. Naltrexone can cause side effects such as nausea, headache, dizziness, and fatigue. Acamprosate may lead to diarrhea, anxiety, and insomnia. Disulfiram can cause drowsiness, headache, and a metallic or garlic-like taste in the mouth. Behavioral therapies and support groups are also integral to treatment, with side effects primarily related to the psychological impact of therapy.

What prior FDA approvals exist?

FDA-approved treatments for alcoholism include medications such as disulfiram, naltrexone, and acamprosate. Disulfiram works by causing unpleasant effects when alcohol is consumed, naltrexone reduces the rewarding effects of alcohol, and acamprosate helps maintain abstinence by stabilizing chemical balance in the brain. These treatments differ from the intranasal oxytocin being studied, which aims to modulate craving and neural activity associated with alcohol use.

What other types of research exist?

Promising novel alternatives to intranasal oxytocin for treating alcoholism in 2024 include: 1) Naltrexone and Acamprosate, which are FDA-approved medications that reduce cravings and relapse rates. 2) Cognitive Behavioral Therapy (CBT), which has shown effectiveness in modifying neural pathways associated with addiction. 3) Emerging treatments like deep brain stimulation (DBS) and transcranial magnetic stimulation (TMS), which are being studied for their potential to modulate neural activity and reduce cravings. 4) Pharmacological agents like baclofen and gabapentin, which are being investigated for their efficacy in reducing alcohol consumption and cravings.

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Hormone Therapy

Oxytocin Nasal Spray for Alcohol and Smoking Cravings

Phase 1

Waitlist Available

Research Sponsored by Brown University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 to 55 years of age

Be between 18 and 65 years old

Must not have

Current use of psychoactive medications or any medication that may interact with oxytocin

Chronic rhinitis or sinusitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5-7 days

Summary

This trial is testing a nasal spray with oxytocin on smokers with alcohol use disorder who are not seeking treatment. The goal is to see if the spray can reduce cravings for alcohol and cigarettes by affecting brain areas related to addiction. Oxytocin has shown preliminary evidence of reducing smoking cravings triggered by cues in smokers.

Who is the study for?

This trial is for non-treatment-seeking adults aged 18-55 who smoke at least 5 cigarettes a day, have an alcohol use disorder, and are in good health. Participants must be right-handed with normal vision or corrected-to-normal vision, not currently using psychoactive medications, and cannot be pregnant or breastfeeding.

What is being tested?

The study tests the effects of oxytocin nasal spray versus placebo on cravings triggered by alcohol-related cues in smokers with an alcohol use disorder. It includes fMRI scans to observe brain responses and measures changes in craving levels, consumption habits, heart rate, blood pressure, and mood.

What are the potential side effects?

Oxytocin may cause side effects such as headaches, nausea, dizziness or emotional changes. Since it's administered via nasal spray, some participants might experience irritation or discomfort in their nose.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5-7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5-7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5-7 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Alcohol craving

Brain activity

Cigarette craving

Secondary study objectives

Ethanol

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Oxytocin nasal sprayActive Control1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Intranasal oxytocin is being studied for its potential to modulate alcohol craving and neural activity by influencing the brain's reward and stress systems. It is thought to enhance social bonding and reduce anxiety, which may help reduce the desire to consume alcohol. Other common treatments for alcoholism include naltrexone, which blocks opioid receptors to reduce the rewarding effects of alcohol, and acamprosate, which stabilizes chemical signaling in the brain to reduce withdrawal symptoms. These treatments are crucial for patients as they target the underlying neural mechanisms of addiction, helping to reduce cravings and prevent relapse.

Effects of Oxytocin Administration on Cue-Induced Craving in Co-occurring Alcohol Use Disorder and PTSD: A Within-Participant Randomized Clinical Trial.Efficacy of Self-Administered Intranasal Oxytocin on Alcohol Use and Craving After Detoxification in Patients With Alcohol Dependence. A Double-Blind Placebo-Controlled Trial.The oxytocin receptor impairs ethanol reward in mice.