Cocaine AddictionPhase 2NCT03423667
Efficacy of N-acetylcysteine on the Craving Symptoms of Abstinent Hospitalized Patients With Cocaine Addiction
A Phase 2 study testing N-acetylcysteine and Lactose powder in people with Cocaine Addiction, run by Salvatore Campanella at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cocaine Addiction
- What is being tested?
- N-acetylcysteine and Lactose powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2019to 17 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Cocaine Addiction
- Being tested
- N-acetylcysteine, Lactose powder
- Keywords
- N-acetylcysteine, Craving
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
N-acetylcysteine (1200 mg) administered twice a day during 5 days
Lactose powderDrug
Placebo comparator.
| Study group | Role | What they receive |
|---|---|---|
| N-acetylcysteine | Experimental | Not described Receives: Drug: N-acetylcysteine |
| Lactose powder | Placebo comparator | Not described Receives: Drug: Lactose powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: 5 days after N-acetylcysteine intake
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)
Measured: Daily from baseline till Day 5 after N-acetylcysteine intake
Relapse rate
Relapse rate
Measured: 1 month after N-acetylcysteine intake
Number of days of abstinence before relapse
Number of days of abstinence before relapse
Measured: From first day of N-acetylcysteine intake until relapse, up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start1 Mar 2019
- Primary completion17 Dec 2024
- Study completion17 Dec 2024
Why it stopped: Difficulties in recruitment (single addictions become rare)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salvatore Campanella
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Salvatore Campanella, Brugmann University Hospital
- Investigators
- Salvatore Campanella, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423667
- Sponsor's protocol ID
- CHUB-Craving NAC
- Status last verified
- Feb 2025
- First submitted
- 30 Jan 2018
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of N-acetylcysteine on the Craving Symptoms of Abstinent Hospitalized Patients With Cocaine Addiction
- ClinicalTrials.gov ID
- NCT03423667
- Acronym / sponsor ID
- CHUB-Craving NAC
- Conditions
- Cocaine Addiction
- Keywords
- N-acetylcysteine, Craving
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in recruitment (single addictions become rare)
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Salvatore CampanellaUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 6 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-acetylcysteine | Experimental | Drug: N-acetylcysteine |
| Lactose powder | Placebo comparator | Drug: Lactose powder |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- Anti-craving or anti-psychotic medication
- Addiction to other drugs (except nicotine or cannabis)
- Neurological medical history
- Psychiatric medical history
- Heavy medical history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetylcysteineN-acetylcysteine (1200 mg) administered twice a day during 5 days | Drug | N-acetylcysteine |
| Lactose powderPlacebo comparator. | Drug | Lactose powder |
Primary outcome
Lickert scale score
Time frame: Baseline
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.
Lickert scale score
Time frame: 5 days after N-acetylcysteine intake
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.
Cocaine craving questionnaire-Brief
Time frame: Daily from baseline till Day 5 after N-acetylcysteine intake
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)
Relapse rate
Time frame: 1 month after N-acetylcysteine intake
Relapse rate
Number of days of abstinence before relapse
Time frame: From first day of N-acetylcysteine intake until relapse, up to 4 years
Number of days of abstinence before relapse
Results and safety
The study was stopped early (reason given: Difficulties in recruitment (single addictions become rare)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Cocaine Addiction
Recruiting
rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder
Cocaine Use, Cocaine Dependence
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Transcranial Direct Current Stimulation (tDCS) for Treatment of Substance Use Disorder
Cocaine Use Disorder, Cocaine Dependence
Active, not recruitingEarly Phase 1
Targeting Drug Memories With Methylphenidate
Substance Use Disorder, Cocaine Use Disorder
RecruitingPhase 1
Safety Study of a Disrupted Adenovirus (Ad) Serotype Cocaine Vaccine for Cocaine-dependent Individuals
Cocaine Dependence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salvatore Campanella principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-acetylcysteine and Lactose powder in people with Cocaine Addiction, run by Salvatore Campanella at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulties in recruitment (single addictions become rare)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lickert scale score (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.