Clinical trial

Efficacy of N-acetylcysteine on the Craving Symptoms of Abstinent Hospitalized Patients With Cocaine Addiction

Name
CHUB-Craving NAC
Description
Cocaine abuse is associated with serious physical, psychiatric and social problems. Addiction results in the compulsive use of a substance with loss of control and persistence despite the negative consequences.The act of re-engaging in the search for drugs is called relapse and a particularly insidious aspect of addiction is that vulnerability to relapse lasts for many years after stopping drug use. The main reason why people continue to use cocaine is because of its influence on the reward system.Indeed, this substance makes it possible to increase the level of dopamine, particularly in the nucleus accumbens.This increase in dopamine is not related to the hedonic pleasure that consumption provides. Instead, it imprints a positive value to enhancers and facilitates the learning of reward associations through the modulation of the cortical and subcortical regions of the brain.In other words, it suggests that users become sensitive to a series of stimuli that combine with a rewarding feeling, which drives them to consume when they encounter them. N-acetylcysteine (NAC) has been used for a long time, mainly as mucolytic. It has also been used as a glutathione antioxidant precursor in the treatment of paracetamol overdose for more than 30 years. NAC has shown beneficial effects in animal models of cocaine addiction by reversing neuroplasticity and reducing the risk of restoring consumer behavior in rodents. Human studies show that NAC is potentially effective in preventing relapse in abstinent patients and ineffective in reducing current consumption. In this study the investigators will test a sample of newly detoxified (and therefore abstinent) patients who have taken a 3-4 week course of treatment, in order determine if NAC can be a useful medication candidate to avoid relapse in patients with cocaine dependence.
Trial arms
Trial start
2019-03-01
Estimated PCD
2030-12-01
Trial end
2030-12-01
Status
Recruiting
Phase
Early phase I
Treatment
N-acetylcysteine
N-acetylcysteine (1200 mg) administered twice a day during 5 days
Arms:
N-acetylcysteine
Lactose powder
Placebo comparator.
Arms:
Lactose powder
Size
80
Primary endpoint
Lickert scale score
Baseline
Lickert scale score
5 days after N-acetylcysteine intake
Cocaine craving questionnaire-Brief
Daily from baseline till Day 5 after N-acetylcysteine intake
Relapse rate
1 month after N-acetylcysteine intake
Number of days of abstinence before relapse
From first day of N-acetylcysteine intake until relapse, up to 4 years
Eligibility criteria
Inclusion Criteria: * Patients addicted to cocaine (according to the DSM V classification) * Patients admitted for three weeks in the unit 73 of the CHU Brugmann Hospital * French speaking Exclusion Criteria: * Anti-craving or anti-psychotic medication * Addiction to other drugs (except nicotine or cannabis) * Neurological medical history * Psychiatric medical history * Heavy medical history * Asthma * Pregnancy * Lactose intolerance
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2023-07-27

1 organization

2 products

1 indication

Product
Lactose