Tobacco Use DisorderPhase 1NCT00258479
Safety of Combining Modafinil and Nicotine Replacement Therapy in Treating Nicotine Dependent Adolescents
A Phase 1 study testing ModafinilNicotine Replacement Therapy and Modafinil in people with Tobacco Use Disorder, run by Catherine Martin, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- ModafinilNicotine Replacement Therapy and Modafinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Dec 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Smokes 10 or more cigarettes per day
Who cannot join
- Current use of any medication for a psychiatric disorder
- Positive drug screen test
- Uses smokeless tobacco
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- ModafinilNicotine Replacement Therapy, Modafinil
- Keywords
- Nicotine Dependence, Nicotine Use Disorder, Tobacco Dependence
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModafinilNicotine Replacement TherapyDrug
Also called Provigil
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.
ModafinilDrug
Also called Provigil
See Modafinil Intervention Description above.
| Study group | Role | What they receive |
|---|---|---|
| Modafinil | Experimental | Not described Receives: Drug: ModafinilNicotine Replacement Therapy; Drug: Modafinil |
| Placebo | Placebo comparator | Not described Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of combination drug treatment and physiological response; measured after treatment with each dose combination
Measured: laboratory session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2005 (estimated)
- Study startJun 2003
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catherine Martin, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Catherine Martin, MD, University of Kentucky
- Investigators
- Catherine Martin, PhD, Study chair, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00258479
- Sponsor's protocol ID
- NIDA-15413
- Other IDs
- R03DA015413, DPMCDA
- Status last verified
- Mar 2012
- First submitted
- 22 Nov 2005
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modafinil and Nicotine in Adolescents: Phase I Trial
- ClinicalTrials.gov ID
- NCT00258479
- Acronym / sponsor ID
- NIDA-15413
- Conditions
- Tobacco Use Disorder
- Keywords
- Nicotine Dependence, Nicotine Use Disorder, Tobacco Dependence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Catherine Martin, MDUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2003
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 24 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Smokes 10 or more cigarettes per day
Key exclusion criteria (3 listed)
- Current use of any medication for a psychiatric disorder
- Positive drug screen test
- Uses smokeless tobacco
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ModafinilNicotine Replacement TherapyAlso: ProvigilA 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. | Drug | Modafinil, Placebo |
| ModafinilAlso: ProvigilSee Modafinil Intervention Description above. | Drug | Modafinil, Placebo |
Primary outcome
Safety of combination drug treatment and physiological response; measured after treatment with each dose combination
Time frame: laboratory session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Martin, PhD study chair
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ModafinilNicotine Replacement Therapy and Modafinil in people with Tobacco Use Disorder, run by Catherine Martin, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of combination drug treatment and physiological response; measured after treatment with each dose combination (time frame: laboratory session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.