Tobacco Use Disorder Clinical Trial
Official title:
Modafinil and Nicotine in Adolescents: Phase I Trial
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.
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).
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT02432066 -
Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions
|
Phase 2 | |
| Completed |
NCT03960138 -
Examining the Effects of Neural Stimulation on Inhibitory Control and Cigarette Smoking
|
N/A | |
| Recruiting |
NCT05030272 -
Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
|
N/A | |
| Completed |
NCT04646668 -
Comparative Abuse Liability Among African American and White Smokers
|
N/A | |
| Completed |
NCT02560324 -
Effect of Ramelteon on Smoking Abstinence
|
Phase 2 | |
| Completed |
NCT02347605 -
Medicinal Nicotine for Preventing Cue Induced Craving
|
N/A | |
| Completed |
NCT01570595 -
Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV
|
Phase 1/Phase 2 | |
| Completed |
NCT01442753 -
Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth
|
N/A | |
| Completed |
NCT01625767 -
Tobacco Approach Avoidance Training for Adolescent Smokers-1
|
Phase 2 | |
| Completed |
NCT01428310 -
Study to Evaluate the Safety and Efficacy of Dietary Supplement Anatabloc in Reducing Daily Smokers' Urge to Smoke
|
Phase 1 | |
| Terminated |
NCT01800500 -
Interest in Smokeless Tobacco Product as a Substitution for Cigarettes in Current Smokers
|
N/A | |
| Active, not recruiting |
NCT01539525 -
Screening to Augment Referral to Treatment- Project START
|
Phase 2 | |
| Completed |
NCT00967005 -
N-Acetyl Cysteine Plus Behavioral Therapy for Nicotine Dependent Pathological Gamblers
|
Phase 2 | |
| Completed |
NCT01337817 -
A Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen in Healthy Smokers
|
Phase 1 | |
| Active, not recruiting |
NCT00751660 -
Screening Methods in Finding Lung Cancer Early in Current or Former Smokers
|
N/A | |
| Completed |
NCT00790569 -
Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking
|
N/A | |
| Completed |
NCT00664261 -
Clinical Effort Against Secondhand Smoke (CEASE) Program or Standard Care in Helping Parents Stop Smoking
|
N/A | |
| Completed |
NCT00158158 -
Effectiveness of Reducing Smoking in Facilitating Smoking Cessation in Adolescents - 2
|
Phase 2/Phase 3 | |
| Completed |
NCT01213524 -
Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia
|
Phase 2 | |
| Completed |
NCT00218179 -
Assessing the Link Between Smoke Carcinogen Biomarkers and Lung Cancer Risk - 1
|
N/A |