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

Sponsor
Catherine Martin, MD (Other)
Overall Status
Completed
CT.gov ID
NCT00258479
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
24
Enrollment
1
Location
3
Arms
102
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Modafinil and Nicotine in Adolescents: Phase I Trial
Study Start Date :
Jun 1, 2003
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Modafinil

Drug: ModafinilNicotine Replacement Therapy
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

    • Drug: Modafinil
    See Modafinil Intervention Description above.
    Other Names:
  • Provigil

    		•
    Placebo Comparator: Placebo

    Drug: ModafinilNicotine Replacement Therapy
    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

    • Drug: Modafinil
    See Modafinil Intervention Description above.
    Other Names:
  • Provigil

    		•
    No Intervention: Nicotine Replacement Therapy

    The effects of nicotine replacement therapy will be investigated - alone and in combination with modafinil - on nicotine withdrawal in nicotine-dependent adolescents.

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Kentucky Lexington Kentucky United States 40509

    Sponsors and Collaborators

    • Catherine Martin, MD
    • National Institute on Drug Abuse (NIDA)

    Investigators

    • Study Chair: Catherine Martin, PhD, University of Kentucky

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Catherine Martin, MD, Princial Investigator, University of Kentucky
    ClinicalTrials.gov Identifier:
    NCT00258479
    Other Study ID Numbers:
    • NIDA-15413
    • R03DA015413
    • DPMCDA
    First Posted:
    Nov 24, 2005
    Last Update Posted:
    May 11, 2017
    Last Verified:
    Mar 1, 2012
    Keywords provided by Catherine Martin, MD, Princial Investigator, University of Kentucky
    Nicotine Dependence
    Nicotine Use Disorder
    Tobacco Dependence
    Additional relevant MeSH terms:
    Tobacco Use Disorder
    Modafinil

    Study Results

    No Results Posted as of May 11, 2017