Evaluation of N-Acetylcysteine Efficacy to Reduce the Craving and to Prolong Abstinence Time of Coca Paste

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.

Conditions

• Cocaine-Related Disorders

Interventions

DRUG

N-Acetylcysteine

In each patient recruited, assignation to placebo or N-Acetylcysteine group treatment wil be performed, after he/she has signed the informed consent. In the first visit, the evaluation by the psychiatrist and with the nurse team (structured evaluation, which includes the CCQ-N-10, CSSA, general health evaluation, urine drug test and basal blood screening), will be carried out. The nurse team will supervise the drug intake and they will observe 2 hours late the ADRs and general health status of patient, who will be responsible for the intake of the following medication doses. Each patient will be asked to attend twice week to his/her treatment center, during four weeks and each patient visit the clinical team will record the primary and secondary outcome.

DRUG

Placebo oral capsule

In each patient recruited, assignation to placebo or N-Acetylcysteine group treatment wil be performed, after he/she has signed the informed consent. In the first visit, the evaluation by the psychiatrist and with the nurse team (structured evaluation, which includes the CCQ-N-10, CSSA, general health evaluation, urine drug test and basal blood screening), will be carried out. The nurse team will supervise the drug intake and they will observe 2 hours late the ADRs and general health status of patient, who will be responsible for the intake of the following medication doses. Each patient will be asked to attend twice week to his/her treatment center, during four weeks and each patient visit the clinical team will record the primary and secondary outcome.

Sponsors & Collaborators

• Comisión Nacional de Investigación Científica y Tecnológica

  collaborator OTHER_GOV

• University of Concepcion, Chile

  lead OTHER

Principal Investigators

• Carmen G Betancur, MD/PhD(c) · Universidad de Concepcion

• Benjamín Vicente, MD/PhD · Universidad de Concepcion

• Carolina P Gómez, PhD · Universidad de Concepcion

• María P Casanova, PhD · Universidad de Concepcion

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-09

Primary Completion

2019-08-09

Completion

2019-08-09

Countries

• Chile

Study Locations