Varying concentrations of alcohol do not alter pharmacokinetics of amphetamine
Alcohol concentrations of between 4 and 40 percent appear to have no significant effect on the pharmacokinetic profile of the psychostimulant amphetamine, a study has found.
The phase I single-dose, open-label study included 32 healthy adults. Participants were randomized to receive amphetamine extended-release orally disintegrating tablet (AMP XR-ODT; 18.8 mg) in one of four sequences: following 240 mL of deionized water or 4, 20 or 40 percent ethanol. Blood samples were collected, and the pharmacokinetic profiles of d- and l-AMP were compared across treatment groups.
No change was seen in the extent of absorption for d- or l-AMP with alcohol coingestion. Moreover, there was no dose-dumping of the extended-release portion of the drug formulation.
The 90 percent CIs for the geometric mean ratios for Cmax (peak serum concentration the drug achieves in a specified test area of the body) and systemic exposure (area under the curve [AUC0]–5, AUClast and AUC0–∞) were in the range of 80 to 125 percent.
Adverse events were mild to moderate in severity, consistent with the known adverse event profile for AMP XR-ODT or alcohol.
The present data are relevant to clinicians who have concerns about alcohol use and/or abuse when treating attention deficit hyperactivity disorder (ADHD), researchers said.
Characterized by inattention, impulsivity and hyperactivity, ADHD can lead to alcohol and other drug (AOD)-related problems. In previous studies, it was shown that the mental disorder contributes to the development of AOD use disorders. The potential role of ADHD in the development of AOD use problems is said to have important implications for prevention and treatment of such problems. [Alcohol Res Health 2002;26:122-129]