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

NCT03556371 | Completed Phase 2 DMC

• 1 other identifier: SA16I0192
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Cocaine; Coca Paste; N-Acetylcysteine; Craving; Abstinence

Outcome Measures

Primary Outcomes (1)

• Maximun Number of Cocaine Base Paste (CBP) Abstinence Days During Four weeks

  This outcome will be measured by recording the days without consumption of CBP during the entire duration of the study. This data will be obtained from the report of each patient as well as through the results of urine drug test at each visit of the patient to the treatment center. Finally, we will considered the maximun number of days of CBP abstinence in the 4 weeks of followed of each patient like outcome measure and we will compare the average between both treatment group.

  Four weeks

Secondary Outcomes (3)

• Change From Baseline Craving for Cocaine Base Paste (CBP) at Four Weeks

  Four weeks

• Relapses Rates According to Arm of Treatment

  Four weeks

• Change From Baseline Score CCQ-N-10 at Four Weeks

  Four weeks

Study Arms (2)

N-acetylcysteine Treatment

EXPERIMENTAL

Oral administration of two capsules, containing 600 milligrams (mg) of N-acetylcysteine each one, twice day (10.00 and 20.00 hours; Total = 2400 mg/day) for four weeks.

Drug: N-Acetylcysteine

Placebo oral capsules

PLACEBO COMPARATOR

Oral administration of two capsules, containing 600 milligrams (mg) of Placebo each one, twice day (10.00 and 20.00 hours; Total = 2400 mg/day) for four weeks.

Drug: Placebo oral capsule

Interventions

N-Acetylcysteine DRUG

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.

Also known as: Nacudec, CVE 1340878

N-acetylcysteine Treatment

Placebo oral capsule DRUG

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.

Placebo oral capsules

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Concepcion, Chile: lead
• Comisión Nacional de Investigación Científica y Tecnológica: collaborator

Study Sites (5)

Centro Terapéutico Anün

Coronel, Concepción, 41900000, Chile

Location

COSAM Lota

Lota, Concepción, 4210000, Chile

Location

COSAM San Pedro de la Paz

San Pedro de la Paz, Concepción, 4130000, Chile

Location

Therapeutic Community La Casa Chica

Talcahuano, Concepción, 4260000, Chile

Location

Psychiatry Service of Hospital Guillermo Grant Benavente

Concepción, 4030000, Chile

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

• Carmen G Betancur, MD/PhD(c)

  Universidad de Concepcion

  PRINCIPAL INVESTIGATOR

• Benjamín Vicente, MD/PhD

  Universidad de Concepcion

  STUDY CHAIR

• Carolina P Gómez, PhD

  Universidad de Concepcion

  STUDY CHAIR

• María P Casanova, PhD

  Universidad de Concepcion

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patients admitted will be randomly assigned to one of the two treatment groups, according to the table previously generated by the pharmaceutical chemist (PhCh) of the research team, according to a block randomization system, every 10 patients. This will be done with an Excel spreadsheet of Random Assignment by Blocks delivered by the statistical engineer of the research team to the PhCh to generate a table with patients belonging to both groups and number the bottles with the different treatments to administer according to this. Later, the PhCh will deliver them already numbered to the clinical team, being this clinical team blind to the treatment that each patient will receive (they will only handle the bottles with the number of each patient, without knowing which group each of them will belong to). In addition, both the NAC and the placebo bottles will have the same pharmaceutical presentation, so, the patients will also be blind to the pharmacotherapy they will receive.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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 CBP within the last month and who have started use 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 will be 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 craving, possible use of for CBP (as well as urine tests), adverse reactions to the indicated medication, among others.

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: June 14, 2018
• Study Start: April 9, 2018
• Primary Completion: August 9, 2019
• Study Completion: August 9, 2019
• Last Updated: September 17, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CL (5)