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

NCT03423667 | Terminated Phase 2

• 1 other identifier: CHUB-Craving NAC
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Addiction

Keywords

N-acetylcysteine; Craving

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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)

  Daily from baseline till Day 5 after N-acetylcysteine intake

• Relapse rate

  Relapse rate

  1 month after N-acetylcysteine intake

• Number of days of abstinence before relapse

  Number of days of abstinence before relapse

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

Study Arms (2)

N-acetylcysteine

EXPERIMENTAL

Drug: N-acetylcysteine

Lactose powder

PLACEBO COMPARATOR

Drug: Lactose powder

Interventions

N-acetylcysteine DRUG

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

N-acetylcysteine

Lactose powder DRUG

Placebo comparator.

Lactose powder

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Salvatore Campanella: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Salvatore Campanella

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Associate FNRS

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 6, 2018
• Study Start: March 1, 2019
• Primary Completion: December 17, 2024
• Study Completion: December 17, 2024
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)