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Alcohol Addiction clinical trials

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NCT ID: NCT05093296 Completed - Clinical trials for Alcohol Use Disorder

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

ON-ICE
Start date: December 2, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

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.

NCT ID: NCT04336293 Completed - Cocaine Addiction Clinical Trials

sTMS for Substance Use-disordered Veterans

Start date: September 7, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if synchronized transcranial magnetic stimulation is safe and tolerable in individuals with cocaine, opioid, or alcohol use disorders.

NCT ID: NCT03212599 Completed - Alcohol Addiction Clinical Trials

Disulfiram as a Modulator of Amyloid Precursor Protein-processing

DIMAP
Start date: May 2013
Phase: N/A
Study type: Observational

A causal therapeutic approach for treatment of Alzheimer's disease has not been established so far. The protein ADAM10 represents a promising target for an A-beta peptide preventing strategy. Treatment of human neuronal cells with Disulfiram, a drug which is used in clinical routine for recrudescence prevention of alcohol dependency, revealed an increased expression of ADAM10. This finding indicates a neuroprotective potential of Disulfiram. The investigators' research purpose aims at the verification of the results obtained in cell culture experiments in the human organism. Therefore, include alcohol addicted patients were included, which take the drug Disulfiram for recrudescence prevention, in our study. Patients are recruited from the patient-collective of the University Medical Center Mainz and the Central Institute for Mental Health Mannheim. Blood samples (max. 5 ml) are taken from the participants before the intake of Disulfiram and about two weeks after treatment. Demographic data are collected (such as age or onset of addiction). Gene expression is analyzed via reverse transcription polymerase chain reaction(RT-PCR) from blood cell-derived messenger ribonucleic acid (mRNA).

NCT ID: NCT02384304 Completed - Alcohol Abuse Clinical Trials

Guided and Unguided Internet Treatment for Problematic Alcohol Use

Start date: December 2012
Phase: N/A
Study type: Interventional

The purpose of this study was to determine whether a 10-week internet-based program based on cognitive behavioral therapy (CBT) is effective in the treatment of alcohol problems, and if having therapist guidance leads to greater effects.