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

NCT00218491 | Completed Phase 2 Results DMC

• 4 other identifiers: NIDA-19903-1R01DA019903R01-19903-1DPMC
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Dependence

Keywords

Cocaine Dependence

Outcome Measures

Primary Outcomes (1)

• 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

  8 weeks

Study Arms (3)

1200mg N-Acetylcysteine

EXPERIMENTAL

1200mg N-Acetylcysteine

Drug: N-Acetylcysteine

2400mg N-Acetylcysteine

EXPERIMENTAL

2400mg N-Acetylcysteine

Drug: N-Acetylcysteine

Matching Placebo

PLACEBO COMPARATOR

Matching Placebo

Drug: Matching Placebo

Interventions

N-Acetylcysteine DRUG

1200mg N-Acetylcysteine

1200mg N-Acetylcysteine

Matching Placebo DRUG

Matching Placebo

Matching Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

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

Results Point of Contact

• Title: Robert Malcolm, MD
• Organization: Medical University of SC

malcomr@musc.edu

843-792-1901

Study Officials

• Robert Malcolm, M.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry, Family Medicine & Pediatrics

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 22, 2005
• Study Start: November 1, 2005
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: January 15, 2019
• Results First Posted: January 15, 2019

Record last verified: 2018-12

Locations

US (1)