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Completed

NCT Number: NCT00258479

Safety of Combining Modafinil and Nicotine Replacement Therapy in Treating Nicotine Dependent Adolescents

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.

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Key information

Conditions

Tobacco Use Disorder Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

16 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Kentucky

Lexington, Kentucky, 40509, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Smokes 10 or more cigarettes per day

Exclusion criteria

  • Current use of any medication for a psychiatric disorder
  • Positive drug screen test
  • Uses smokeless tobacco

Treatment and study plan

ModafinilNicotine Replacement Therapy

Drug

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.

Other names: Provigil

Modafinil

Drug

See Modafinil Intervention Description above.

Other names: Provigil

Primary outcomes

  1. Safety of combination drug treatment and physiological response; measured after treatment with each dose combination

    Time frame: laboratory session

Sponsors and collaborators

Lead sponsor

Catherine Martin, MD

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Modafinil and Nicotine in Adolescents: Phase I Trial

Important dates

Study start
2003
Primary completion
2011
Study completion
2011
First posted
Nov 24, 2005
Registry last updated
May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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