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

NCT ID: NCT00258479

Last Updated: 2017-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2011-12-31

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.

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).

Conditions

Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Modafinil

Group Type: EXPERIMENTAL

ModafinilNicotine Replacement Therapy

Intervention Type: 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.

Modafinil

Intervention Type: DRUG

See Modafinil Intervention Description above.

Placebo

Group Type: PLACEBO_COMPARATOR

ModafinilNicotine Replacement Therapy

Intervention Type: 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.

Modafinil

Intervention Type: DRUG

See Modafinil Intervention Description above.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Modafinil

See Modafinil Intervention Description above.

Intervention Type: DRUG

Other Intervention Names

Provigil; Provigil

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Catherine Martin, MD

OTHER

Sponsor Role: lead

Responsible Party

Catherine Martin, MD

Princial Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Catherine Martin, PhD

Role: STUDY_CHAIR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

R03DA015413

Identifier Type: NIH

Identifier Source: secondary_id

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DPMCDA

Identifier Type: -

Identifier Source: secondary_id

NIDA-15413

Identifier Type: -

Identifier Source: org_study_id