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

NCT00258479 | Completed Phase 1 DMC

• 3 other identifiers: NIDA-15413R03DA015413DPMCDA
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Disorder

Keywords

Nicotine Dependence; Nicotine Use Disorder; Tobacco Dependence

Outcome Measures

Primary Outcomes (1)

• Safety of combination drug treatment and physiological response; measured after treatment with each dose combination

  laboratory session

Study Arms (3)

Modafinil

EXPERIMENTAL

Drug: ModafinilNicotine Replacement Therapy; Drug: Modafinil

Placebo

PLACEBO COMPARATOR

Drug: ModafinilNicotine Replacement Therapy; Drug: Modafinil

Nicotine Replacement Therapy

NO INTERVENTION

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

Interventions

ModafinilNicotine Replacement Therapy 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.

Also known as: Provigil

Modafinil; Placebo

Modafinil DRUG

See Modafinil Intervention Description above.

Also known as: Provigil

Modafinil; Placebo

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Smokes 10 or more cigarettes per day

You may not qualify if:

• Current use of any medication for a psychiatric disorder
• Positive drug screen test
• Uses smokeless tobacco

Sponsors & Collaborators

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

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40509, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Catherine Martin, PhD

  University of Kentucky

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Princial Investigator

Study Record Dates

• First Submitted: November 22, 2005
• First Posted: November 24, 2005
• Study Start: June 1, 2003
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 11, 2017

Record last verified: 2012-03

Locations

US (1)