• Safety of combination drug treatment and physiological response; measured after treatment with each dose combination [ Time Frame: laboratory session ] [ Designated as safety issue: Yes ]
  

Drug: Modafinil

A dose escalation design for all subjects includes eight dose conditions tested across a 12-day study (nicotine low and high, modafinil low and high and 4 combinations). After day 1 placebo dose, placebo sessions will occur in random order during 1) low dose testing, 2) high dose testing, and 3) dose-combination testing.

Modafinil and nicotine will each be tested alone, with participants exposed to low active doses prior to higher doses. Dose interactions will then be determined, with low doses of each drug tested in combination followed by low-high dose combinations, prior to the high-high dose combination. All doses will be administered under double-blind, double dummy procedures. A nicotine patch (0, 7 or 14 mg doses) will be applied at 7 am on the morning of test. Modafinil doses will be prepared in size 00 opaque capsules. The modafinil dose (0, 100, 200 mg) will be administered at 5 PM.

Drug: Nicotine Replacement Therapy
See Modafinil Intervention Description above.

NRT is a critical part of treating nicotine withdrawal symptoms, such as cravings, sleeplessness, poor concentration, and anxiety. The addition of modafinil, a promising pharmacologic agent, may enhance the effectiveness of NRT by further reducing inattention and depressed mood. The purpose of this study is to examine the safety of using both modafinil and NRT in treating nicotine dependent adolescents. In addition, this study will examine the effects of modafinil and NRT, alone and in combination, on alleviating symptoms of inattention and depressed mood.

Participants in this 12-day dose escalation study will be tested under eight different dose conditions. Modafinil and NRT will first be tested alone; participants will be exposed to low doses prior to higher doses of medication. Various modafinil-NRT dose combinations will then be tested. Modafinil will be administered at 5 p.m. each day, and NRT will be self-administered at the start of each day in which a participant must complete lab tests. The following measures will be obtained at study visits occurring before and after the various modafinil-NRT dose combinations: nicotine withdrawal symptoms, medication side effects, activity level, cardiovascular response, and profile of mood states (POMS).