NCT00136825

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2003

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

January 12, 2017

Status Verified

August 1, 2007

First QC Date

August 25, 2005

Last Update Submit

January 11, 2017

Conditions

Cocaine-Related Disorders

Keywords

cocainetreatment

Outcome Measures

Primary Outcomes (1)

  • Tolerability of N-Acetylcysteine

    Measured throughout both inpatient stays

Secondary Outcomes (2)

  • Reactivity to pictures of cocaine

    Measured after 4th and final dose of med/placebo during each hospital stay

  • Cocaine withdrawal

    Measured at admission, then discharge, for each hospital stay

Study Arms (2)

2

PLACEBO COMPARATOR

Identical appearing placebo pill containing lactose powder, packaged to have similar odor as N-Acetylcysteine in capsule form

Drug: Placebo

1

EXPERIMENTAL

N-Acetylcysteine

Drug: N-Acetylcysteine

Interventions

N-AcetylcysteineDRUG
1
PlaceboDRUG
2

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Not seeking treatment for drugs of abuse
  • Diagnostic and Statistical Manual of Mental Disorders-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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (2)

  • LaRowe SD, Mardikian P, Malcolm R, Myrick H, Kalivas P, McFarland K, Saladin M, McRae A, Brady K. Safety and tolerability of N-acetylcysteine in cocaine-dependent individuals. Am J Addict. 2006 Jan-Feb;15(1):105-10. doi: 10.1080/10550490500419169.

    PMID: 16449100BACKGROUND

  • LaRowe SD, Myrick H, Hedden S, Mardikian P, Saladin M, McRae A, Brady K, Kalivas PW, Malcolm R. Is cocaine desire reduced by N-acetylcysteine? Am J Psychiatry. 2007 Jul;164(7):1115-7. doi: 10.1176/ajp.2007.164.7.1115.

    PMID: 17606664RESULT

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Steven D LaRowe, Ph.D.

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 29, 2005

Study Start

March 1, 2003

Study Completion

September 1, 2005

Last Updated

January 12, 2017

Record last verified: 2007-08

Locations

US(1)