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

Catherine Martin, MD

Status and phase: Completed; Phase 1

Conditions: Tobacco Use Disorder

Treatments: Drug: ModafinilNicotine Replacement Therapy; Drug: Modafinil

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00258479

R03DA015413 (U.S. NIH Grant/Contract)

DPMCDA

NIDA-15413

Details and patient eligibility

About

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.

Full 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).

Enrollment: 24 patients

Sex: All

Ages: 16 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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24 participants in 3 patient groups, including a placebo group

Modafinil

Experimental group

Treatment:

Drug: Modafinil

Drug: ModafinilNicotine Replacement Therapy

Placebo

Placebo Comparator group

Treatment:

Drug: Modafinil

Drug: ModafinilNicotine Replacement Therapy

Nicotine Replacement Therapy

No Intervention group

Description:

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