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TerminatedPhase 2

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

Key facts

Who runs it
Salvatore Campanella
Where
Belgium1 site in 1 countryChoose a country to see its sites
Trial code
Status
Terminated
Phase
Phase 2
People taking part
33 people enrolled
Started
1 Mar 2019
Ended
17 Dec 2024
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • N-acetylcysteine
  • Lactose powder
Record updated
7 February 2025
Why it stopped
Difficulties in recruitment (single addictions become rare)

Who can take part

Age
18 years to 80 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Anti-craving or anti-psychotic medication
  • Addiction to other drugs (except nicotine or cannabis)
  • Psychiatric medical history
  • Neurological medical history
  • Heavy medical history
  • Asthma
  • Pregnancy
  • Lactose intolerance

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

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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.

The 2 groups in the trial

  • N-acetylcysteineTreatment being tested
  • Lactose powderPlacebo, for comparison

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
7 February 2025