Safety of Combining Modafinil and Nicotine Replacement Therapy in Treating Nicotine Dependent Adolescents
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      Nicotine is one of the most widely abused substances in the United States. Nicotine
      replacement therapy (NRT) is currently an effective treatment for nicotine dependence;
      however, even with NRT most people fail at quitting smoking after their first attempt.
      Modafinil is a promising drug that may be useful in treating nicotine dependent individuals.
      The purpose of this study is to evaluate the safety of the combination of modafinil and NRT
      in treating nicotine dependent adolescent smokers.
    

Detailed description: 
      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).
    

Intervention name(s): ModafinilNicotine Replacement Therapy; Modafinil
Intervention type(s): Drug; Drug
Intervention description(s): A dose escalation design includes eight dose conditions across a 12-day study (nicotine low-high, modafinil low-high and 4 combinations). After day 1 placebo dose, placebo sessions occur in random order during low dose, high dose, and dose-combination testing. Modafinil and nicotine are tested alone with subjects exposed to low active doses prior to higher doses. Dose interactions will be determined with low doses tested in combination followed by low-high dose combinations then high-high dose combination. Doses are administered under double-blind, double dummy procedures. A nicotine patch (0, 7 or 14 mg doses) is applied at 7 am. Modafinil doses are prepared in size 00 opaque capsules. The modafinil dose (0, 100, 200 mg) is administered at 5 PM.; See Modafinil Intervention Description above.
Other intervention name(s): Provigil; Provigil
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nicotine Dependence; Nicotine Use Disorder; Tobacco Dependence