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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Concepcion, Chile
• Collaborator: Comisión Nacional de Investigación Científica y Tecnológica
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion Criteria:

• To be a patient asking for treatment in any clinical center participating of our research

• To be 18 years old or older.

• To meet the criteria for cocaine (coca paste / CBP) use disorder according to the DSM-V (Therefore they must have at least one year using this substance)

• To have the CBP as the main drug of consumption.

• To have consumed CBP during the month prior to the start our treatment.

• To have a history of any previous CBP withdrawal symptoms or at the time of admission to the study.

• To accept to participate in this study and to sign informed consent previous to enter to it.

Exclusion Criteria:

• To be pregnant or breastfeeding.

• To have dependence of any substance other than CBP, alcohol, nicotine or marijuana.

• To have a severe alcohol withdrawal syndrome during the study.

• To be a delirium at the time of the study.

• To have a psychiatric disorder that decreases their ability to consent or participate adequately in our study (mental retardation, psychotic disorder, generalized disorder of development or another similar disorder).

• To have an active peptic ulcer.

• To have a active bronchial asthma or severe respiratory disease.

• To have epilepsy or a history of seizures.

• To have a serious medical illness known or in treatment (ex.: cancer, liver or kidney failure).

• To be using drugs such as penicillin, tetracycline, carbamazepine, nitroglycerin, antitussives or inhibitors of bronchial secretion, at the time of the study.

• To have a history of allergy to the NAC.