Evaluation of N-Acetylcysteine Efficacy to Reduce the Craving and to Prolong THE Abstinence Time of Coca Paste
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 5
- 主要终点
- Maximun Number of Cocaine Base Paste (CBP) Abstinence Days During Four weeks
研究概览
简要总结
- 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.
详细描述
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Quality assurance plan: With the monitoring of our research through the supervision of the Contract Research Organization named South Cone Alliance.
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Data checks: With the monitoring of our research through the supervision of the Contract Research Organization named South Cone Alliance.
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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.
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Data dictionary: None
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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:
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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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
N-acetylcysteine Treatment
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.
干预措施: N-Acetylcysteine (Drug)
Placebo oral capsules
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.
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Maximun Number of Cocaine Base Paste (CBP) Abstinence Days During Four weeks
时间窗: 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.
次要结局
- Change From Baseline Craving for Cocaine Base Paste (CBP) at Four Weeks(Four weeks)
- Change From Baseline Score CCQ-N-10 at Four Weeks(Four weeks)
- Relapses Rates According to Arm of Treatment(Four weeks)
研究者
Carmen Betancur, MD
Assistant Professor
University of Concepcion, Chile