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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Catherine Martin, MD, University of Kentucky
ClinicalTrials.gov Identifier:
NCT00258479
First received: November 22, 2005
Last updated: March 12, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Tobacco Use Disorder
Drug: ModafinilNicotine Replacement Therapy
Drug: Modafinil
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modafinil and Nicotine in Adolescents: Phase I Trial

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Safety of combination drug treatment and physiological response; measured after treatment with each dose combination [ Time Frame: laboratory session ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: June 2003
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Modafinil 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.
Other Name: Provigil
Drug: Modafinil
See Modafinil Intervention Description above.
Other Name: Provigil
Placebo Comparator: Placebo 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.
Other Name: Provigil
Drug: Modafinil
See Modafinil Intervention Description above.
Other Name: Provigil
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.

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).

  Eligibility

Ages Eligible for Study:   16 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00258479

Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40509
Sponsors and Collaborators
University of Kentucky
Investigators
Study Chair: Catherine Martin, PhD University of Kentucky
  More Information

No publications provided

Responsible Party: Catherine Martin, MD, Princial Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT00258479     History of Changes
Other Study ID Numbers: NIDA-15413, R03DA015413, R03 DA015413, DPMCDA
Study First Received: November 22, 2005
Last Updated: March 12, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Kentucky:
Nicotine Dependence
Nicotine Use Disorder
Tobacco Dependence

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Nicotine
Nicotine polacrilex
Modafinil
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on April 20, 2014