Cocaine-Related DisordersPhase 2NAC-PBCNCT03556371

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

A Phase 2 study testing N-Acetylcysteine in people with Cocaine-Related Disorders, run by University of Concepcion, Chile at 5 sites in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cocaine-Related Disorders
What is being tested?: N-Acetylcysteine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 140 participants
Where: 5 sitesChile
Study dates: 9 Apr 2018to 9 Aug 2019
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Chile5 sites

Psychiatry Service of Hospital Guillermo Grant Benavente
Concepción, 4030000
Centro Terapéutico Anün
Coronel, Concepción, 41900000
COSAM Lota
Lota, Concepción, 4210000
COSAM San Pedro de la Paz
San Pedro de la Paz, Concepción, 4130000
Therapeutic Community La Casa Chica
Talcahuano, Concepción, 4260000

Other trials in Chile

About this study

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

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.

Read the detailed description

Quality assurance plan: With the monitoring of our research through the supervision of the Contract Research Organization named South Cone Alliance.
Data checks: With the monitoring of our research through the supervision of the Contract Research Organization named South Cone Alliance.
Source data verification: All information of the patients recruited in our study was obtained by the research team directly from each patient, without using to external sources.
Data dictionary: None
Standard Operating Procedures: Each patient must attend twice a week (every 3 days approximately) to assessment in her/him mental health center with the research team. The interventions are detailed below:
Number 1 Visit:

Reception by the psychiatrist:

Explanation of the nature of the study and signing of informed consent.
Clinical evaluation with Semi-Structured Interview and application of MINI.
Selection of patients who meet criteria, assignment of the respective entry code to the study and entry to the study with it.
Delivery of medicine bottle with the first 28 capsules according to previous randomization (treatment for the 1st week)

Nursing Reception (initial structured evaluation):

Application of urine drug test (for detection of cocaine, marijuana, benzodiazepines, opiates, amphetamines.) If positive for opioids, the patient is excluded from this study.
Anthropometric evaluation (measure, weigh, BMI)
Hemodynamic evaluation (blood pressure (BP), body temperature (BT), heart rate (HR) and breathing rate (BR)) to each patient.
Performance of baseline blood test: blood count, glycemia, liver tests and creatininemia.
Drug administration.
Observation for 2 hours of the patient, in which progress is made in:
Application of CCQ-N-10, CSSA and Clinical Global Impression (CGI) scales .
Record of adverse reactions / side effects of the medication and
Final hemodynamic evaluation (BP, BT, HR, BR).
Delivery of card of citations for next assessments (or controls). Number 2 Visit: Nursing follow-up (follow-up file):
Record of Abstinence Days (last use of CBP)
Urine drug test application (for cocaine detection).
Anthropometric evaluation (measure, weigh, BMI)
Hemodynamic evaluation ( BP, BT, HR and BR).
Asking about withdrawal symptoms (CSSA application)
Asking about craving (VAS-craving and CCQ-N-10 application)
Asking about adherence to a treatment: application of Morisky-Green Test
UKU Scale Application
CGI application.
Agreement about time for next assesments (or controls). Number 3 Visit: Idem to the number 2 visit more delivery of second medicine bottle with 28 capsules for the second week of treatment by the doctor of the research team. Number 4 Visit: Idem to the visit number 2 Number 5 Visit: Idem to the visit number 2 more delivery of third medicine bottle with 28 capsules for the third week of treatment by the doctor of the research team. Number 6 Visit: Idem to the visit number 2 Number 7 Visit: Idem to the visit number 2 more delivery of fourth medicine bottle with 28 capsules for the fourth week of treatment by the doctor of the research team. Number 8 visit: Idem to the visit number 2. Number 9 visit: Idem to the visit number 2 more the closing of the study.
Sample size assessment: The minimum size necessary for a definitive trial in this case would be 106 subjects calculated according to a power of β = 0.8 to detect at least one effect size of the treatment of d = 0.55 , which corresponds to effect size calculated with data from previous studies with this drug in cocaine-dependent patients (LaRowe y cols. Safety and tolerability of N-acetylcysteine in cocaine-dependent individuals. American Journal on Addictions . 2006: 15(1), 105-110). Considering that the analysis of results would be done through a test more powerful than t for independent samples and a level of significance α = 0.05 will be accepted in a two-tailed design.
Plan for missing data: First: the missing data pattern will be analyzed Second: The mechanism of missing data will be studied to see if it is possible to predict the loss pattern and evaluate the possible bias for missing data. Third: If it is found that the missing data mechanism generates bias, multiple imputation will be used for the analyzes.
Statistical analysis plan: The main outcomes of this test will be described as follows:
the proportion of patients who agreed to enter the trial,
the differences between those who entered and those who refused,
the characteristics of the sample,
adherence to treatment, and
the number and characteristics of dropouts during follow-up.
The characteristics of the participants in each arm of the trial will be compared, but will not be subjected to statistical tests. The variables to be compared will be sex, age, comorbidity, PBC consumption time, severity of CBP use disorder and baseline CBP craving to verify homogeneity between groups.
Primary outcomes will be compared at four-week follow-up, as follows:
After verifying the distribution of the mean duration of CBP abstinence days in both groups, a model will be analyzed by adjusting according to the severity of the CBP use disorder in the baseline (this is the most relevant variable reported in the literature that could influence to the abstinence) and by adjusting according to previous abstinence days, it means, days without coca paste use before to enter this research.
Differences in primary outcome by group (with severity adjustment and previous abstinence days) will be reported along with their 95% confidence intervals.
The results will be analyzed using the statistical program SPSS and R. According to the variables of result to be evaluated, the analyzes will be:
For tolerability assessment: Proportion comparison test (normal approximation, sample sizes allow) for Adverse Drug Reactions (ADR) for each of the 8 post-basal measurement instances.
For safety assessment: proportion of patients with mild, moderate and severe ADR per group analyzed with the Brunner-Munzel test, extension of the Mann-Whitney U for ordinal data with many repetitions.
To assess coca paste (CBP) abstinence time: Abstinence days will be compared using a Kaplan-Mier estimator. In the case of finding a signifcant increase in CBP abstinence days in the NAC treatment group, a correlation study (Pearson, if there is normality, Spearman otherwise) will be made between the quantitative variables measured to the individuals and days of abstinence.
To evaluate the rate of falls in CBP consumption: Fall rates in CBP consumption will be compared using a generalized linear mixed model, with Poisson response and times between exponential relapses. In case of over-dispersion, a model with Negative Binomial response will be considered.
For Craving evaluation: it will be analyzed by means of test comparisons of means (Student T, under normality verified with Kolmogorov Smirnov, or U Mann Whitney, otherwise) for independent samples, considering the initial measurements (before there is much desertion ).
A comparison of means between experimental and control groups will be performed using repeated measures ANOVA (if normality is verified with Kolmogorov Smirnov and Fisher homoscedasticity) or non-parametric ANOVA analysis for repeated measures (otherwise).
It is also important to mention that incomplete data due to abandonment of the study, whether or not there is a return, should be considered for the analysis.

Conditions: Cocaine-Related Disorders
Being tested: N-Acetylcysteine, Placebo oral capsule
Keywords: Cocaine, Coca Paste, N-Acetylcysteine, Craving, Abstinence
Medical subject headings: Cocaine-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

N-AcetylcysteineDrug
Also called Nacudec, CVE 1340878
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 capsuleDrug
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.

Study groups in NCT03556371
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Placebo oral capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Four weeks

Secondary outcomes (3)

Change From Baseline Craving for Cocaine Base Paste (CBP) at Four Weeks
This outcome will be measured watching the change from the baseline in the values of Visual Analog Scale for Craving (VAS-Craving) at the 4 weeks.
Measured: Four weeks
Relapses Rates According to Arm of Treatment
We will measure the number of relapses in the CBP consumption of patients in both treatment groups, which will be calculated by counting the number of patients who fall into the consumption of CBP during the time of treatment and the proportion of these in each group.
Measured: Four weeks
Change From Baseline Score CCQ-N-10 at Four Weeks
This outcome will be measured watching the change from the baseline in the values of the Cocaine Craving Questionnaire Now-10 (CCQ-N-10) at the 4 weeks.
Measured: Four weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Apr 20189 Aug 2019

First posted14 Jun 2018
Study start9 Apr 2018
Primary completion9 Aug 2019
Study completion9 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cocaine-Related DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03556371
Sponsor's protocol ID: SA16I0192
Acronym: NAC-PBC
Status last verified: Sep 2019
First submitted: 5 Apr 2018
Last updated: 17 Sep 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Asperger's Disorder, Asperger Disorder
Recruiting
Transcranial Direct Current Stimulation (tDCS) for Treatment of Substance Use Disorder
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RecruitingPhase 1
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All Cocaine-Related Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of N-Acetylcysteine Efficacy to Reduce the Craving and to Prolong THE Abstinence Time of Coca Paste
ClinicalTrials.gov ID: NCT03556371
Acronym / sponsor ID: NAC-PBC / SA16I0192
Conditions: Cocaine-Related Disorders
Keywords: Cocaine, Coca Paste, N-Acetylcysteine, Craving, Abstinence
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: University of Concepcion, ChileUniversity, hospital or other
Collaborators: Comisión Nacional de Investigación Científica y Tecnológica
Study start: 9 Apr 2018 (actual)
Primary completion: 9 Aug 2019 (actual)
Study completion: 9 Aug 2019 (actual)
First posted: 14 Jun 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Quality assurance plan: With the monitoring of our research through the supervision of the Contract Research Organization named South Cone Alliance.
Data checks: With the monitoring of our research through the supervision of the Contract Research Organization named South Cone Alliance.
Source data verification: All information of the patients recruited in our study was obtained by the research team directly from each patient, without using to external sources.
Data dictionary: None
Standard Operating Procedures: Each patient must attend twice a week (every 3 days approximately) to assessment in her/him mental health center with the research team. The interventions are detailed below:
Number 1 Visit:

Reception by the psychiatrist:

Explanation of the nature of the study and signing of informed consent.
Clinical evaluation with Semi-Structured Interview and application of MINI.
Selection of patients who meet criteria, assignment of the respective entry code to the study and entry to the study with it.
Delivery of medicine bottle with the first 28 capsules according to previous randomization (treatment for the 1st week)

Nursing Reception (initial structured evaluation):

Application of urine drug test (for detection of cocaine, marijuana, benzodiazepines, opiates, amphetamines.) If positive for opioids, the patient is excluded from this study.
Anthropometric evaluation (measure, weigh, BMI)
Hemodynamic evaluation (blood pressure (BP), body temperature (BT), heart rate (HR) and breathing rate (BR)) to each patient.
Performance of baseline blood test: blood count, glycemia, liver tests and creatininemia.
Drug administration.
Observation for 2 hours of the patient, in which progress is made in:
Application of CCQ-N-10, CSSA and Clinical Global Impression (CGI) scales .
Record of adverse reactions / side effects of the medication and
Final hemodynamic evaluation (BP, BT, HR, BR).
Delivery of card of citations for next assessments (or controls). Number 2 Visit: Nursing follow-up (follow-up file):
Record of Abstinence Days (last use of CBP)
Urine drug test application (for cocaine detection).
Anthropometric evaluation (measure, weigh, BMI)
Hemodynamic evaluation ( BP, BT, HR and BR).
Asking about withdrawal symptoms (CSSA application)
Asking about craving (VAS-craving and CCQ-N-10 application)
Asking about adherence to a treatment: application of Morisky-Green Test
UKU Scale Application
CGI application.
Agreement about time for next assesments (or controls). Number 3 Visit: Idem to the number 2 visit more delivery of second medicine bottle with 28 capsules for the second week of treatment by the doctor of the research team. Number 4 Visit: Idem to the visit number 2 Number 5 Visit: Idem to the visit number 2 more delivery of third medicine bottle with 28 capsules for the third week of treatment by the doctor of the research team. Number 6 Visit: Idem to the visit number 2 Number 7 Visit: Idem to the visit number 2 more delivery of fourth medicine bottle with 28 capsules for the fourth week of treatment by the doctor of the research team. Number 8 visit: Idem to the visit number 2. Number 9 visit: Idem to the visit number 2 more the closing of the study.
Sample size assessment: The minimum size necessary for a definitive trial in this case would be 106 subjects calculated according to a power of β = 0.8 to detect at least one effect size of the treatment of d = 0.55 , which corresponds to effect size calculated with data from previous studies with this drug in cocaine-dependent patients (LaRowe y cols. Safety and tolerability of N-acetylcysteine in cocaine-dependent individuals. American Journal on Addictions . 2006: 15(1), 105-110). Considering that the analysis of results would be done through a test more powerful than t for independent samples and a level of significance α = 0.05 will be accepted in a two-tailed design.
Plan for missing data: First: the missing data pattern will be analyzed Second: The mechanism of missing data will be studied to see if it is possible to predict the loss pattern and evaluate the possible bias for missing data. Third: If it is found that the missing data mechanism generates bias, multiple imputation will be used for the analyzes.
Statistical analysis plan: The main outcomes of this test will be described as follows:
the proportion of patients who agreed to enter the trial,
the differences between those who entered and those who refused,
the characteristics of the sample,
adherence to treatment, and
the number and characteristics of dropouts during follow-up.
The characteristics of the participants in each arm of the trial will be compared, but will not be subjected to statistical tests. The variables to be compared will be sex, age, comorbidity, PBC consumption time, severity of CBP use disorder and baseline CBP craving to verify homogeneity between groups.
Primary outcomes will be compared at four-week follow-up, as follows:
After verifying the distribution of the mean duration of CBP abstinence days in both groups, a model will be analyzed by adjusting according to the severity of the CBP use disorder in the baseline (this is the most relevant variable reported in the literature that could influence to the abstinence) and by adjusting according to previous abstinence days, it means, days without coca paste use before to enter this research.
Differences in primary outcome by group (with severity adjustment and previous abstinence days) will be reported along with their 95% confidence intervals.
The results will be analyzed using the statistical program SPSS and R. According to the variables of result to be evaluated, the analyzes will be:
For tolerability assessment: Proportion comparison test (normal approximation, sample sizes allow) for Adverse Drug Reactions (ADR) for each of the 8 post-basal measurement instances.
For safety assessment: proportion of patients with mild, moderate and severe ADR per group analyzed with the Brunner-Munzel test, extension of the Mann-Whitney U for ordinal data with many repetitions.
To assess coca paste (CBP) abstinence time: Abstinence days will be compared using a Kaplan-Mier estimator. In the case of finding a signifcant increase in CBP abstinence days in the NAC treatment group, a correlation study (Pearson, if there is normality, Spearman otherwise) will be made between the quantitative variables measured to the individuals and days of abstinence.
To evaluate the rate of falls in CBP consumption: Fall rates in CBP consumption will be compared using a generalized linear mixed model, with Poisson response and times between exponential relapses. In case of over-dispersion, a model with Negative Binomial response will be considered.
For Craving evaluation: it will be analyzed by means of test comparisons of means (Student T, under normality verified with Kolmogorov Smirnov, or U Mann Whitney, otherwise) for independent samples, considering the initial measurements (before there is much desertion ).
A comparison of means between experimental and control groups will be performed using repeated measures ANOVA (if normality is verified with Kolmogorov Smirnov and Fisher homoscedasticity) or non-parametric ANOVA analysis for repeated measures (otherwise).
It is also important to mention that incomplete data due to abandonment of the study, whether or not there is a return, should be considered for the analysis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
N-acetylcysteine Treatment	Experimental	Drug: N-AcetylcysteineOral 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.
Placebo oral capsules	Placebo comparator	Drug: Placebo oral capsuleOral 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (11 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
N-AcetylcysteineAlso: Nacudec, CVE 1340878In 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	N-acetylcysteine Treatment
Placebo oral capsuleIn 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 capsules

Primary outcome

Maximun Number of Cocaine Base Paste (CBP) Abstinence Days During Four weeks
Time frame: 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.

3 secondary outcomes

Change From Baseline Craving for Cocaine Base Paste (CBP) at Four Weeks
Time frame: Four weeks
Relapses Rates According to Arm of Treatment
Time frame: Four weeks
Change From Baseline Score CCQ-N-10 at Four Weeks
Time frame: Four weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carmen G Betancur, MD/PhD(c) principal investigator

Universidad de Concepcion

Benjamín Vicente, MD/PhD study chair

Universidad de Concepcion

Carolina P Gómez, PhD study chair

Universidad de Concepcion

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing N-Acetylcysteine in people with Cocaine-Related Disorders, run by University of Concepcion, Chile at 5 sites in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximun Number of Cocaine Base Paste (CBP) Abstinence Days During Four weeks (time frame: Four weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03556371.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.