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TerminatedNCT03423667Updated Feb 7, 2025

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

A Phase 2 interventional study of N-acetylcysteine and Lactose powder in Cocaine Addiction, sponsored by Salvatore Campanella. Terminated at 1 site in Belgium. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-07.

Sponsored by Salvatore Campanella · Phase 2, Interventional, and Treatment

Why this study was terminated
Difficulties in recruitment (single addictions become rare)

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Phase
Phase 2
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

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.

Read the detailed 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.

Initial investigations regarding the effect of dopamine on the reward system were conducted primarily on the mesolimbic dopaminergic pathway linking the ventral tegmental area to the nucleus accumbens. More recent work has now recognized the role of mesocortical and mesostriatal pathways, but dopamine is far from being the only neurotransmitter involved.

Glutamate also plays a central role in the neuroadaptive changes resulting from chronic exposure to cocaine. Preclinical research has shown that intense exposure to cocaine increases the extracellular level of glutamate in the nucleus accumbens. Cocaine-induced chronic adaptations to glutamatergic homeostasis within the nucleus accumbens include downregulation of the cystine-glutamate (also called xc) exchanger on glial cells and the glial glutamate transporter 1 (GLT-1).

The cystine-glutamate exchanger is an amino acid anti porter that is generally involved in the exchange of extracellular L-cystine (L-Cys2) and intracellular L-glutamate (L-Glu) across the cell plasma membrane. Existing data indicate that these exchanges being diminished, they contribute to abnormal glutamate signaling in the corticostriatal pathway and that these cocaine-induced changes in the Xc system are necessary to restore consumption behavior in the rodent. This imbalance between synaptic and non-synaptic glutamate in the corticostriatal pathway impairs communication between the prefrontal cortex and the nucleus accumbens. As a result, long-term use of cocaine decreases an individual's ability to inhibit the research and consumption behaviors of the product. This results in a relapse syndrome characteristic of addictions.The Xc system would therefore be a potential therapeutic target for the treatment of cocaine addiction.

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. One study has even shown that NAC administered to rodents before they consume cocaine prevents the installation of research behavior due to plasticity. Its ability to regulate the activity of the cystine-glutamate antiporter and the biosynthesis of glutathione would be key to its therapeutic efficacy. NAC would also have the ability to reverse the disruption of GLT-1 receptor function. An interesting study has also shown that NAC-treated rats show an attenuation of dopamine increase in the nucleus accumbens when cocaine is taken, which deserves further investigation.

Four studies showed NAC's potential to reduce craving, desire to consume, and cocaine search in abstinent consumers. However these studies present only preliminary data because the samples are not large enough and they are mostly open studies (participants are informed about the nature and dosage of the medication, without placebo group). A more recent study of a larger sample of subjects still actively using cocaine found that NAC reduces craving and increases time to relapse only in a small subset of subjects who are already abstinent, particularly with the highest doses.This study was a double blind study with a placebo group. This suggests that NAC is potentially effective in preventing relapse in abstinent patients and ineffective in reducing current consumption.

A question that arises is the frequency with which NAC should be administered. In the majority of the studies cited above, the product was administered several times over a shorter or longer period. However, studies have shown that a single dose (2400 mg on a human) can have measurable neurochemical effects, although it is not clear that these changes are sufficient to produce measurable changes in behavior.Clinical trials have used doses ranging from 1200 to 3600 mg daily for varying periods of time, and further studies would also be needed to determine the optimal amount to avoid a relapse.

The latest study on the subject suggested that NAC may be useful for preventing relapse of abstinent patients rather than reducing the consumption of patients still taking cocaine. However, this effect was not part of the main assumptions and was highlighted in additional exploratory analyzes. The vast majority of patients in this study were therefore not abstinent.

In this study, therefore, the investigators will only test a sample of newly detoxified (and therefore abstinent) patients who have taken a 3-4 week course of treatment, in order to increase the power of the analyzes and determine if NAC can be a useful medication candidate to avoid relapse in patients with cocaine dependence.

02

Conditions studied

  • Cocaine Addiction

Keywords

  • N-acetylcysteine
  • Craving
03

In context

Cocaine-Related Disorders

416 studies on the registry are indexed under Cocaine-Related Disorders; 12 are open to participants now.

This study's enrollment of 33 is below the median of 60 across 313 interventional studies indexed under Cocaine-Related Disorders.

Browse Cocaine-Related Disorders studies →

Lead sponsor

This is the only study on the registry with Salvatore Campanella as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    N-acetylcysteine

    Drug: N-acetylcysteine

  • Placebo comparator
    Lactose powder

    Drug: Lactose powder

Interventions

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

  • DrugLactose powder

    Placebo comparator.

06

What researchers measure

Primary outcomes

  1. Lickert scale score

    Images and videos will be presented to the participants. These will be either neutral or related to drugs consumption (2 images and 1 video of each context). The participants will evaluate their desire to consume, their craving and attraction to each image on a Lickert scale ranging from 0 to 20.

    Time frame: Baseline

  2. Lickert scale score

    Images and videos will be presented to the participants. These will be either neutral or related to drugs consumption (2 images and 1 video of each context). The participants will evaluate their desire to consume, their craving and attraction to each image on a Lickert scale ranging from 0 to 20.

    Time frame: 5 days after N-acetylcysteine intake

  3. Cocaine craving questionnaire-Brief

    The CCQ-Brief consists of 10 items from the CCQ-Now questionnaire, designed to measure a patient's desire to use cocaine. It is intended for use in routine clinical practice (score from 10 till 70)

    Time frame: Daily from baseline till Day 5 after N-acetylcysteine intake

  4. Relapse rate

    Relapse rate

    Time frame: 1 month after N-acetylcysteine intake

  5. Number of days of abstinence before relapse

    Number of days of abstinence before relapse

    Time frame: From first day of N-acetylcysteine intake until relapse, up to 4 years

07

Study locations

1 site
  • CHU Brugmann
    Brussels, 1020, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2019 to primary completion in Dec 2024, 69 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 30, 2018
First posted
Feb 6, 2018
StartActual
Mar 1, 2019
Primary completionActual
Dec 17, 2024
CompletionActual
Dec 17, 2024
Last update
Feb 7, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03423667
Lead sponsor
Salvatore Campanella
Responsible party
Salvatore Campanella (Research Associate FNRS, Brugmann University Hospital) — Sponsor-investigator
First posted
Feb 6, 2018
Start date
Mar 1, 2019
Primary completion
Dec 17, 2024
Completion
Dec 17, 2024
Last update
Feb 7, 2025

Study contacts

Salvatore Campanella
principal investigator · CHU Brugmann

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Acetylcysteine

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