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Effectiveness of N-Acetylcysteine (NAC) in Treating Cocaine Dependent Individuals - 1 (NAC)

Primary Purpose

Cocaine Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
N-Acetylcysteine
N-Acetylcysteine
Matching Placebo
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring Cocaine Dependence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Meets DSM-IV criteria for cocaine dependence, as determined by a mini-SCID interview Currently dependent on cocaine Seeking treatment for cocaine abuse at the time of study entry Currently uses cocaine by smoking, nasal, or intravenous route of administration. Stable physical and mental health, as judged by an interview and physical examination If female, demonstrates a negative pregnancy test and agrees to use an adequate method of contraception for the duration of the study Lives within a 50 mile radius of the research program center and has reliable transportation Exclusion Criteria: Meets DSM-IV criteria for dependence on any psychoactive substance other than cocaine, alcohol, nicotine, or marijuana Physiological dependence on alcohol, which requires medical detoxification History of significant liver, kidney, endocrine, cardiac (e.g., arrhythmia requiring medication, angina pectoris, myocardial infarction), stroke, seizure, neurological, non-drug-related psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorders (e.g., homocystinuria) History of an adverse reaction to cocaine, including loss of consciousness, chest pain, psychosis, or seizure History of adverse reaction or hypersensitivity to N-acetyl cystine (NAC), or a similar drug Significant active medical or psychiatric illness that might inhibit the ability to complete the study Active high blood pressure, defined as a mean of three sitting blood pressure readings of 145/95 or higher within a 10-day period History of or current asthma Occasional or daily use of albuterol or other beta-agonist inhalers Use of carbamazepine, phenytoin, nitrous oxide, methotrexate, 6 azauridine triacetate, or nitroglycerin within the 2 weeks prior to study entry Use of very large doses of folate, cyanocobalamine (vitamin B12), or pyridoxine (vitamin B6) as prescribed by a health care professional; individuals taking very large doses of these vitamins on a self-initiated basis may enter the study if they are willing to stop use 14 days prior to study entry and to use a standard generic multiple vitamin instead Pregnant or breastfeeding Required by the court to obtain treatment for cocaine dependence Not seeking treatment for cocaine dependence Anticipating elective surgery or hospitalization within 20 weeks of study entry Failure to have a consistent residence for the 4 weeks prior to study entry History of childhood or adult seizures Participated in cocaine treatment (clinical or research) within 30 days of study entry

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1200mg N-Acetylcysteine

2400mg N-Acetylcysteine

Matching Placebo

Arm Description

1200mg N-Acetylcysteine

2400mg N-Acetylcysteine

Matching Placebo

Outcomes

Primary Outcome Measures

Number of Participants That Achieved Study Compliance
Drug and placebo compliance were measured by urine riboflavin levels. Study compliance was defined as 80% or greater weekly urine riboflavin levels equal to or greater than 1500 ng/ml

Secondary Outcome Measures

Full Information

First Posted
September 16, 2005
Last Updated
December 21, 2018
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00218491
Brief Title
Effectiveness of N-Acetylcysteine (NAC) in Treating Cocaine Dependent Individuals - 1
Acronym
NAC
Official Title
A Controlled Trial of N-Acetylcysteine (NAC) for Cocaine Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Currently, no effective drug treatment exists for cocaine dependence. Glutamate levels are disrupted with long-term cocaine use. N-acetyl cysteine (NAC) is a drug that is metabolized by the body to form cysteine, an active compound that normalizes glutamate levels. The purpose of this study is to determine the safety and effectiveness of NAC in treating cocaine dependent individuals.
Detailed Description
Currently, no effective pharmacological treatment exists for cocaine dependence. Long-term use of cocaine disrupts normal glutamate levels. If addicts stop using cocaine, glutamate levels drop, which encourages addicts to continue seeking the drug. NAC is a drug that increases intracellular cysteine levels, which in turn leads to normalization of glutamate levels. Currently, NAC is used for the treatment of cystic fibrosis, heart disease, and acetaminophen overdose. Since NAC has the capability of restoring normal glutamate levels, it holds potential as a treatment for cocaine dependence. The purpose of this study is to determine the safety and effectiveness of NAC in treating cocaine dependent individuals. In addition, this study will evaluate cocaine craving and withdrawal symptoms in individuals taking NAC. Participants in this double-blind, placebo-controlled trial will be randomly assigned to receive either NAC or placebo. All participants will undergo an initial evaluation, which will include a physical examination, an electrocardiogram, blood samples, urine tests, and cue reactivity measures. Participants in the NAC group will receive either 600 mg or 1200 mg of NAC, two times each day for 8 weeks. In addition, all participants will receive cognitive behavioral therapy throughout the study on a weekly basis. Cocaine use will be confirmed by a urine drug screen test, three times each week. Participants will be assessed on a number of biomedical and psychosocial variables known to influence cocaine treatment outcomes. After Week 2, participants will repeat the cue reactivity procedures, which will include measuring a participant's craving response when exposed to conditioned reminders of prior cocaine use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
Keywords
Cocaine Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1200mg N-Acetylcysteine
Arm Type
Experimental
Arm Description
1200mg N-Acetylcysteine
Arm Title
2400mg N-Acetylcysteine
Arm Type
Experimental
Arm Description
2400mg N-Acetylcysteine
Arm Title
Matching Placebo
Arm Type
Placebo Comparator
Arm Description
Matching Placebo
Intervention Type
Drug
Intervention Name(s)
N-Acetylcysteine
Intervention Description
1200mg N-Acetylcysteine
Intervention Type
Drug
Intervention Name(s)
N-Acetylcysteine
Intervention Description
2400mg N-Acetylcysteine
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Intervention Description
Matching Placebo
Primary Outcome Measure Information:
Title
Number of Participants That Achieved Study Compliance
Description
Drug and placebo compliance were measured by urine riboflavin levels. Study compliance was defined as 80% or greater weekly urine riboflavin levels equal to or greater than 1500 ng/ml
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meets DSM-IV criteria for cocaine dependence, as determined by a mini-SCID interview Currently dependent on cocaine Seeking treatment for cocaine abuse at the time of study entry Currently uses cocaine by smoking, nasal, or intravenous route of administration. Stable physical and mental health, as judged by an interview and physical examination If female, demonstrates a negative pregnancy test and agrees to use an adequate method of contraception for the duration of the study Lives within a 50 mile radius of the research program center and has reliable transportation Exclusion Criteria: Meets DSM-IV criteria for dependence on any psychoactive substance other than cocaine, alcohol, nicotine, or marijuana Physiological dependence on alcohol, which requires medical detoxification History of significant liver, kidney, endocrine, cardiac (e.g., arrhythmia requiring medication, angina pectoris, myocardial infarction), stroke, seizure, neurological, non-drug-related psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorders (e.g., homocystinuria) History of an adverse reaction to cocaine, including loss of consciousness, chest pain, psychosis, or seizure History of adverse reaction or hypersensitivity to N-acetyl cystine (NAC), or a similar drug Significant active medical or psychiatric illness that might inhibit the ability to complete the study Active high blood pressure, defined as a mean of three sitting blood pressure readings of 145/95 or higher within a 10-day period History of or current asthma Occasional or daily use of albuterol or other beta-agonist inhalers Use of carbamazepine, phenytoin, nitrous oxide, methotrexate, 6 azauridine triacetate, or nitroglycerin within the 2 weeks prior to study entry Use of very large doses of folate, cyanocobalamine (vitamin B12), or pyridoxine (vitamin B6) as prescribed by a health care professional; individuals taking very large doses of these vitamins on a self-initiated basis may enter the study if they are willing to stop use 14 days prior to study entry and to use a standard generic multiple vitamin instead Pregnant or breastfeeding Required by the court to obtain treatment for cocaine dependence Not seeking treatment for cocaine dependence Anticipating elective surgery or hospitalization within 20 weeks of study entry Failure to have a consistent residence for the 4 weeks prior to study entry History of childhood or adult seizures Participated in cocaine treatment (clinical or research) within 30 days of study entry
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Malcolm, M.D.
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of N-Acetylcysteine (NAC) in Treating Cocaine Dependent Individuals - 1

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