Oxytocin and Naltrexone: Investigation of Combined Effects on Stress- and Alcohol Cue-induced Craving in Alcohol Use Disorder

Summary

Alcohol use disorder (AUD) is a chronic relapsing disorder. Alcohol craving, a hallmark symptom of AUD that drives relapse in patients, is only insufficiently treated by existing medication. One promising new compound is Oxytocin (OXY), which showed beneficial effects on alcohol craving in preliminary clinical studies. Additionally, OXY seems to enhance effects of established medication, specifically Naltrexone (NTX), an opioid-antagonist which is approved for AUD treatment via positive synergism on neurotransmitter levels. The proposed two-armed, 1:1 randomized, double-blind, parallel group trial seeks to test the putative synergistic effects of combined intranasal OXY spray (24 IU) + oral NTX (50mg) against Placebo spray + oral NTX (50mg) on alcohol craving (primary outcome) in male and female patients with AUD that suffer from high alcohol craving, within the framework of a validated alcohol cue-and stress-exposure task (i.e. a combined Trier Stress Test and alcohol cue-exposure) that was established for screening new medications in AUD and determine their effects on craving and relapse risk. Treatment effects on additional neurobiological and biochemical markers of craving that show strong associations to individual relapse risk, will serve as secondary outcomes. Collection and analysis of follow-up data (90 days) will be performed to determine whether treatment effects relate to patient outcome.

The clinical trial period for an individual participant consists of a screening visit (visit 1), a baseline visit (visit 2) and two treatment visits (visits 3 and 4)(all within equal or less than ten days) followed by a 90 days (+/- 7 days) follow-up phase with two visits (visits 5 and 6) at day 30 (± 7 days) and day 90 (± 7 days). Visits 1 to 4 will be conducted while participants are undergoing standard in-patient treatment at the Department of Addictive Behavior and Addiction medicine at the Central Institute of Mental Health (CIMH) in Mannheim, Germany, for the medical condition under investigation.

Conditions

• Alcohol Use Disorder
• Alcoholism
• Alcohol Addiction

Interventions

DRUG

Oxytocin nasal spray

24 I.U. Oxytocin nasal Spray will be administered twice on two separate trial days.

DRUG

Naltrexone Pill

All participants will receive 50mg Naltrexone daily as oral tablet throughout the study

DRUG

Placebo

Placebo nasal spray (same composition as the verum oxytocin spray except for the active ingredient oxytocin)

Sponsors & Collaborators

• Heidelberg University - Institute of Medical Biometry (IMBI)

  collaborator UNKNOWN

• Heidelberg University - Coordination Centre for Clinical Trials (KKS) of Heidelberg University

  collaborator UNKNOWN

• German Federal Ministry of Education and Research

  collaborator OTHER_GOV

• Central Institute of Mental Health, Mannheim

  lead OTHER

Principal Investigators

• Patrick Bach, MD · Central Institute of Mental Health, Mannheim

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-02

Primary Completion

2023-07-15

Completion

2023-09-27

Countries

• Germany

Study Locations