The main purpose of this study is to determine the outcome of a drug combination treatment on detoxified and stabilized methamphetamine (METH) and/or cocaine (COC) dependent users. The combination regimen consists of oral administration of a generic immediate-release methylphenidate (MPh-IR) formulation (e.g., Ritalin®) and a novel delayed, pulsatile-release formulation of the antiemetic ondansetron (Ond-PR002). Various psychological assessment tools and functional magnetic resonance imaging (fMRI) will be used to assess the treatment outcome. In addition to the treatment outcome measures, we will determine whether the 14-day, once-a-day treatment leads to significant changes in the pharmacokinetic/pharmacodynamic (PK/PD), safety and tolerability parameters of MPh-IR and/or Ond-PR002 formulations and drug-drug interactions between the two drugs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Drug: OND-PR002 Single daily oral doses of 8 mg Ond-PR002 Drug: MPh-IR Single daily oral doses of 20 mg MPh-IR
Single daily oral doses
Duke Addictions Clinic
Durham, North Carolina, United States
Duke Clinical Research Unit
Durham, North Carolina, United States
SouthLight
Raleigh, North Carolina, United States
Efficacy of combined Ond-PR002 and MPh-IR treatment
Efficacy of combined Ond-PR002 and MPh-IR treatment in reducing the Visual Analogue Scale (VAS), Cocaine Selective Severity Assessment (CSSA) and Amphetamine Cessation Symptom Assessment (ACSA) craving scores in abstinent METH/COC abusers. Changes in cue-reactivity and inhibitory control deficits will be also assessed using functional magnetic resonance imaging (fMRI).
Time frame: 15 days
Safety of combined MPh-IR + Ond-PR002 treatment
Number of subjects with clinically significant changes in vital signs, electrocardiogram (ECG), hematology or chemistry panel measurements and number of subjects with self-reported or observed adverse events or serious adverse events will be recorded.
Time frame: 15 days
Changes in the PK parameters of Ond-PR002 PK after 14-day treatment
Standard PK parameters of Ond-PR002 (e.g., maximum serum concentrations, time to reach max. concentration, apparent volume of distribution, etc.) will be calculated based on the serum drug concentrations, and statistical differences between Day 1 and Day 14 will be determined.
Time frame: 15 days
Changes in the PK parameters of MPh-IR PK after 14-day treatment
Standard PK parameters of MPh-IR on Day 1 and Day 14 will be calculated and statistically compared as described for Ond-PR002.
Time frame: 15 days
Tolerability of combined MPh-IR + Ond-PR002 treatment
Number of subjects with clinically significant changes in vital signs, electrocardiogram (ECG), hematology or chemistry panel measurements and number of subjects with self-reported or observed adverse events or serious adverse events will be recorded.
Time frame: 15 days
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