Evaluation of N-Acetylcysteine Efficacy to Reduce the Craving and to Prolong Abstinence Time of Coca Paste
Status:
Completed
Trial end date:
2019-08-09
Target enrollment:
Participant gender:
Summary
- Introduction: The Cocaine Base Paste (or Coca Paste or CBP), a highly toxic and
addictive smokable drug (a by-product of the cocaine extraction chain), has become in
the last years a real social scourge for Chile. Today, there is not a pharmacological
treatment approved in Chile neither around the world for the management of the
withdrawal syndrome nor the dependence caused by the use of this substance. The
N-Acetylcysteine (NAC), a derivative of the amino acid cysteine, with mucolytic and
antioxidant properties, used in Chile since several years for bronchopulmonary
treatments, as well as a hepatic and renal protector, among others, has shown, in animal
and human research, that has benefits to reduce the craving for cocaine and in the
management of the withdrawal syndrome of this and other psychoactive substances.
- Objectives: To evaluate whether the use of NAC in patients with problematic CBP
consumption reduce the craving for this substance and prolong its abstinence time.
- Methods: will be carried out a randomized, double-blind, controlled, phase II-b clinical
trial, with a parallel group design with CBP dependent patients in different outpatient
care units in the province of Concepción, Chile. Patients who meet the cocaine (CBP)
consumption disorder criteria, who have used of CBP within the last month and who have
started to use it one year at least prior to admission to the study, will be selected
from among the consulting population. Patients who agree to participate in the study
must sign an informed consent form before being clinically evaluated. During the
evaluations, semi-structured interviews and standardized questionnaires were used to
investigate both consumption habits and symptoms of withdrawal and intensity of CBP
craving, among others. All patients in the study will be attended twice weekly to
treatment centers for four weeks, reporting their craving for CBP, the use of this
substance (as well as urine tests), adverse reactions to the indicated medication, among
others.
- Expected results: It is expected that, thanks to the use of NAC, patients with CBP use
disorder entered to this study significantly reduce their craving to consume this
substance, they can prolong the abstinence time of it and they can reduce their falls in
CBP consumption.
Phase:
Phase 2
Details
Lead Sponsor:
University of Concepcion, Chile
Collaborator:
Comisión Nacional de Investigación Científica y Tecnológica