Substance Abuse Clinical Trial
Official title:
Rivastigmine and Huperzine A as Treatments for Cocaine Dependence
The purpose of this study is to determine the safety and effects of rivastigmine and huperzine A (HupA), potential treatments for cocaine abuse, when used before experimental administration of cocaine, on a number of physical and psychological measures.
The purpose of this study is to evaluate the interactions between cocaine and oral
rivastigmine and between cocaine and oral huperzine A (HupA).
The following Specific Aims are proposed: 1. Among cocaine-dependent, non-treatment seeking
participants, to establish the ability of rivastigmine (3 or 6 mg, daily) or HupA (0.4 or
0.8 mg, daily), as compared to placebo, to reduce cocaine-induced craving (0, 20, and 40 mg,
IV) and to reduce reinforcing effects produced by cocaine (20 mg, IV/infusion). Hypothesis.
Relative to placebo-treated participants, treatment with rivastigmine or HupA will reduce
cocaine-induced craving and choices for cocaine.
2. To determine the safety of rivastigmine and HupA in cocaine-dependent participants who
receive cocaine in a laboratory setting. Hypothesis 2A. Relative to placebo-treated
participants, treatment with rivastigmine or HupA will not increase the adverse events
produced by cocaine. Hypothesis 2B. Relative to placebo-treated participants, treatment with
rivastigmine or HupA will reduce cocaine-induced increases in heart rate and blood pressure.
3. To determine the effects of AChE inhibition on plasma levels of cocaine and cocaine
metabolites. Hypothesis 3A. Relative to placebo-treated participants, treatment with
rivastigmine, but not HupA, will be associated with increased plasma levels of cocaine.
Hypothesis 3B. Relative to placebo-treated participants, treatment with rivastigmine, but
not HupA, will be associated with increased formation of ecgonine and benzoylecgonine, and
decreased formation of ecgonine methylester.
4. a) provide a more frequent measure of heart rate (15 sec vs. 5 minutes) and b) measure a
new dependent variable, physical activity, on days with and without cocaine exposure.
Public Health Significance: Cocaine abuse is an important health problem that is associated
with serious medical, psychiatric, social, and economic consequences. No medications are
currently available for prevention of relapse in patients who are addicted to cocaine, and
compounds such as rivastigmine and HupA are predicted to be useful for this indication. The
testing of HupA is particularly exciting since it has antioxidant and neuroprotective
properties that may also contribute to its efficacy as a treatment medication for cocaine
dependence.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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