Efficacy of N-acetylcysteine on the Craving Symptoms of Abstinent Hospitalized Patients With Cocaine Addiction
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03423667|
Recruitment Status : Not yet recruiting
First Posted : February 6, 2018
Last Update Posted : July 12, 2018
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
N-acetylcysteine (1200 mg) administered twice a day during 5 days
|Placebo Comparator: Lactose powder||
Drug: Lactose powder
- 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
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
|Contact: Salvatore Campanella||3224772851||Salvatore.CAMPANELLA@chu-brugmann.be|
|CHU Brugmann||Not yet recruiting|
|Brussels, Belgium, 1020|
|Contact: Salvatore Campanella|
|Principal Investigator: Salvatore Campanella|
|Principal Investigator:||Salvatore Campanella||CHU Brugmann|