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

NCT03423667 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-02-07

No results posted yet for this study

Summary

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.

Conditions

  • Cocaine Addiction

Interventions

DRUG

N-acetylcysteine

N-acetylcysteine (1200 mg) administered twice a day during 5 days

DRUG

Lactose powder

Placebo comparator.

Sponsors & Collaborators

  • Salvatore Campanella

    lead OTHER

Principal Investigators

  • Salvatore Campanella · CHU Brugmann

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2024-12-17
Completion
2024-12-17

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03423667 on ClinicalTrials.gov