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

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute on Drug Abuse (NIDA)
• Treatments: Acetylcysteine; Cocaine; N-monoacetylcystine

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