Effectiveness of N-Acetylcysteine in Treating Cocaine Dependent Individuals - 1

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00136825
First received: August 25, 2005
Last updated: August 17, 2007
Last verified: August 2007
  Purpose

Recent findings have suggested that N-acetylcysteine (NAC) substantially reduces cocaine drug-seeking behavior in formerly cocaine dependent rats. The purpose of this study is to determine the safety, tolerability, and cue reactivity effects of NAC in cocaine dependent individuals and non-dependent healthy controls.


Condition Intervention Phase
Cocaine-Related Disorders
Drug: N-Acetylcysteine
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: N-Acetylcysteine as Treatment in Cocaine Addiction

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Tolerability of N-Acetylcysteine [ Time Frame: Measured throughout both inpatient stays ]

Secondary Outcome Measures:
  • Reactivity to pictures of cocaine [ Time Frame: Measured after 4th and final dose of med/placebo during each hospital stay ]
  • Cocaine withdrawal [ Time Frame: Measured at admission, then discharge, for each hospital stay ]

Enrollment: 17
Study Start Date: March 2003
Study Completion Date: September 2005
Arms Assigned Interventions
Placebo Comparator: 2
Identical appearing placebo pill containing lactose powder, packaged to have similar odor as N-Acetylcysteine in capsule form
Drug: Placebo
Experimental: 1
N-Acetylcysteine
Drug: N-Acetylcysteine

Detailed Description:

Recent findings have suggested that N-acetylcysteine (NAC) substantially reduces cocaine-primed drug-seeking behavior in formerly cocaine dependent rats. The purpose of this study is to determine the safety, tolerability, and cue reactivity effects of NAC in cocaine dependent individuals and non-dependent healthy controls.

Participants in this study will include 20 non-treatment seeking cocaine dependent individuals and 12 healthy, non-dependent controls. Participants will be recruited via word-of-mouth and advertisements. Cocaine dependent participants will undergo two 3-day hospital stays. Healthy controls will be followed throughout the study on an outpatient basis. All participants will be randomly assigned to receive either 600 mg of NAC or placebo. Medication or placebo will be administered twice each day. Participants will be evaluated for side effects throughout the study. After administration of the final dose of medication or placebo, participants will undergo cue reactivity testing. This will include a standardized protocol of slides demonstrating cocaine acquisition, use of cocaine, and cocaine-related paraphernalia. Before, during, and after cue reactivity procedures, standardized behavioral and cognitive scales will be used to assess cocaine craving, cocaine seeking, and subjective effects of the cocaine "high." The following week participants will be crossed over so that they will receive the other treatment. All study procedures will be performed a second time. Participants will be contacted during Week 3 in order to determine if any residual side effects or adverse events occurred from the medication and treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Not seeking treatment for drugs of abuse
  • DSM-IV diagnosis of cocaine dependence (not applicable for individuals enrolling as healthy controls)
  • Positive urine drug screen test for cocaine (not applicable for individuals enrolling as healthy controls)
  • Females must use adequate forms of contraception throughout the study
  • Stable residence for the 30 days prior to enrollment
  • No history of N-acetylcysteine within the 7 days prior to enrollment
  • Nicotine smokers staying at the inpatient unit must use the nicotine patch during inpatient stay

Exclusion Criteria:

  • Dependence on any psychoactive substance other than alcohol, nicotine, or marijuana; control subjects cannot be dependent on cocaine
  • Need for medication detoxification for alcohol
  • History of psychiatric disorders, including depression, bipolar disorder, post traumatic stress disorder, dementia, and organic brain disorder
  • Suicidal or homicidal behavior within the 30 days prior to enrollment
  • History of psychotic symptoms, including those observed during cocaine use
  • History of serious medical illness, including cardiovascular disease, angina, myocardial infarction, liver disease, and kidney disease
  • History of neurologic, metabolic, neoplastic, nutritional, inflammatory, or endocrine disorders
  • Court requirement to receive treatment
  • Expecting elective surgery within the 5 weeks prior to enrollment
  • Known hypersensitivity to N-acetylcysteine
  • Use of antidepressants (such as selective serotonin reuptake inhibitors or tricyclics), dopamine agonists, or psychotropic medications (such as anticonvulsants, antipsychotics, anxiolytics, or psychostimulants) within the 14 days prior to enrollment
  • Pregnant or breastfeeding
  • History of asthma
  • History of seizures
  • Participation in treatment for cocaine abuse within the 30 days prior to enrollment
  • Lactose intolerance
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136825

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Investigators
Principal Investigator: Steven D LaRowe, Ph.D. Medical University of South Carolina
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00136825     History of Changes
Other Study ID Numbers: NIDA-18501-1, F32-18501-1, DPMC
Study First Received: August 25, 2005
Last Updated: August 17, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on September 18, 2014