search
Back to results

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

Primary Purpose

Cocaine-Related Disorders

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
N-Acetylcysteine
Placebo
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring cocaine, treatment

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 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

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

2

1

Arm Description

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

N-Acetylcysteine

Outcomes

Primary Outcome Measures

Tolerability of N-Acetylcysteine

Secondary Outcome Measures

Reactivity to pictures of cocaine
Cocaine withdrawal

Full Information

First Posted
August 25, 2005
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT00136825
Brief Title
Effectiveness of N-acetylcysteine in Treating Cocaine Dependent Individuals - 1
Official Title
N-acetylcysteine as Treatment in Cocaine Addiction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders
Keywords
cocaine, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Identical appearing placebo pill containing lactose powder, packaged to have similar odor as N-Acetylcysteine in capsule form
Arm Title
1
Arm Type
Experimental
Arm Description
N-Acetylcysteine
Intervention Type
Drug
Intervention Name(s)
N-Acetylcysteine
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Tolerability of N-Acetylcysteine
Time Frame
Measured throughout both inpatient stays
Secondary Outcome Measure Information:
Title
Reactivity to pictures of cocaine
Time Frame
Measured after 4th and final dose of med/placebo during each hospital stay
Title
Cocaine withdrawal
Time Frame
Measured at admission, then discharge, for each hospital stay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven D LaRowe, Ph.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

Citations:
PubMed Identifier
16449100
Citation
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.
Results Reference
background
PubMed Identifier
17606664
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs