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Trial record 5 of 78 for:    Not yet recruiting Studies | amphetamine OR cocaine OR heroin OR marijuana OR ketamine

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

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ClinicalTrials.gov Identifier: NCT03423667
Recruitment Status : Not yet recruiting
First Posted : February 6, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Salvatore Campanella, Brugmann University Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Cocaine Addiction Drug: N-acetylcysteine Drug: Lactose powder Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of N-acetylcysteine on the Craving Symptoms of Abstinent Hospitalized Patients With Cocaine Addiction
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: N-acetylcysteine Drug: N-acetylcysteine
N-acetylcysteine (1200 mg) administered twice a day during 5 days

Placebo Comparator: Lactose powder Drug: Lactose powder
Placebo comparator.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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)

  4. Relapse rate [ Time Frame: 1 month after N-acetylcysteine intake ]
    Relapse rate

  5. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423667


Contacts
Contact: Salvatore Campanella 3224772851 Salvatore.CAMPANELLA@chu-brugmann.be

Locations
Belgium
CHU Brugmann Not yet recruiting
Brussels, Belgium, 1020
Contact: Salvatore Campanella         
Principal Investigator: Salvatore Campanella         
Sponsors and Collaborators
Salvatore Campanella
Investigators
Principal Investigator: Salvatore Campanella CHU Brugmann

Responsible Party: Salvatore Campanella, Research Associate FNRS, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT03423667     History of Changes
Other Study ID Numbers: CHUB-Craving NAC
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Salvatore Campanella, Brugmann University Hospital:
N-acetylcysteine
Craving

Additional relevant MeSH terms:
Cocaine-Related Disorders
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Acetylcysteine
N-monoacetylcystine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Protective Agents