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NCT00258479 Clinical Trial

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

Tobacco Use Disorder Clinical Trial

Official title:
Modafinil and Nicotine in Adolescents: Phase I Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00258479
Other study ID # NIDA-15413
Secondary ID R03DA015413DPMCD
Status Completed
Phase Phase 1
First received November 22, 2005
Last updated May 10, 2017
Start date June 2003
Est. completion date December 2011

Study information
Verified date March 2012
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 40 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.
• Modafinil
See Modafinil Intervention Description above.

Locations
Country Name City State
United States University of Kentucky Lexington Kentucky

Sponsors (2)
Lead Sponsor Collaborator
Catherine Martin, MD National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety of combination drug treatment and physiological response; measured after treatment with each dose combination laboratory session
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