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

National Institutes of Health (NIH)

Status and phase

Completed

Phase 1

Conditions

Cocaine-Related Disorders

Treatments

Drug: Placebo

Drug: N-Acetylcysteine

Study type

Interventional

Funder types

NIH

Identifiers

NCT00136825

F32-18501-1

DPMC

NIDA-18501-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts 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