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Trial record 63 of 240 for:    (armodafinil)

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00258479
Recruitment Status : Completed
First Posted : November 24, 2005
Last Update Posted : May 11, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Catherine Martin, MD, University of Kentucky

Tracking Information
First Submitted Date  ICMJE November 22, 2005
First Posted Date  ICMJE November 24, 2005
Last Update Posted Date May 11, 2017
Study Start Date  ICMJE June 2003
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2008)
Safety of combination drug treatment and physiological response; measured after treatment with each dose combination [ Time Frame: laboratory session ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 23, 2005)
Safety of combination drug treatment and physiological response; measured after each dose combination
Change History Complete list of historical versions of study NCT00258479 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of Combining Modafinil and Nicotine Replacement Therapy in Treating Nicotine Dependent Adolescents
Official Title  ICMJE Modafinil and Nicotine in Adolescents: Phase I Trial
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tobacco Use Disorder
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Modafinil
    Interventions:
    • Drug: ModafinilNicotine Replacement Therapy
    • Drug: Modafinil
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: ModafinilNicotine Replacement Therapy
    • Drug: Modafinil
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2012)
24
Original Enrollment  ICMJE
 (submitted: November 23, 2005)
100
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00258479
Other Study ID Numbers  ICMJE NIDA-15413
R03DA015413 ( U.S. NIH Grant/Contract )
DPMCDA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Catherine Martin, MD, University of Kentucky
Study Sponsor  ICMJE Catherine Martin, MD
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Study Chair: Catherine Martin, PhD University of Kentucky
PRS Account University of Kentucky
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP