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

PHASE2CompletedINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

April 9, 2018

Primary Completion Date

August 9, 2019

Study Completion Date

August 9, 2019

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.

Trial Locations (5)

4030000

Psychiatry Service of Hospital Guillermo Grant Benavente, Concepción

4130000

COSAM San Pedro de la Paz, San Pedro de la Paz

4210000

COSAM Lota, Lota

4260000

Therapeutic Community La Casa Chica, Talcahuano

41900000

Centro Terapéutico Anün, Coronel

All Listed Sponsors
collaborator

Comisión Nacional de Investigación Científica y Tecnológica

OTHER_GOV

lead

University of Concepcion, Chile

OTHER

NCT03556371 - Evaluation of N-Acetylcysteine Efficacy to Reduce the Craving and to Prolong Abstinence Time of Coca Paste | Biotech Hunter | Biotech Hunter