Safety of Combining Modafinil and Nicotine Replacement Therapy in Treating Nicotine Dependent Adolescents
Modafinil and Nicotine in Adolescents: Phase I Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40509
- University of Kentucky
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
|
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:
See Modafinil Intervention Description above.
Other Names:
|
|
Experimental: Modafinil
|
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:
See Modafinil Intervention Description above.
Other Names:
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety of combination drug treatment and physiological response; measured after treatment with each dose combination
Time Frame: laboratory session
|
laboratory session
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Catherine Martin, PhD, University of Kentucky
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Tobacco Use Disorder
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Central Nervous System Stimulants
- Wakefulness-Promoting Agents
- Modafinil
Other Study ID Numbers
- NIDA-15413
- DPMCDA (Other Identifier: NIDA)
- R03DA015413 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.