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SmokingPhase 2NCT00549640

Testing Methylphenidate for Smoking Abstinence

A Phase 2 study testing Methylphenidate in people with Smoking, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cigarette smoking continues to be a major public health problem. Tobacco dependence interventions, as recommended by the USPHS Clinical Practice Guideline are not effective for all smokers. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Smoking
What is being tested?
Methylphenidate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteUnited States
Study dates
Jan 2008to May 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Are between 18 to 65 years of age
  • Have smoked cigarettes daily for the past 6-months and are currently smoking > 10 cigarettes/day
  • Are willing to make an attempt to stop smoking
  • Are able to participate fully in all aspects of the study
  • Have been provided with, understand, and have signed the informed consent

Who cannot join

  • Have clinically significant levels of current depression as assessed by CESD and determined by the physician; or have a life-time diagnosis of bipolar disorder, schizophrenia or dementia as determined by physician investigator
  • Are currently (in previous 30 days) using any tobacco treatment program (i.e., behavioral therapy, nicotine replacement therapy, bupropion SR, varenicline, clonidine or nortriptyline)
  • Have used an investigational drug within the 30 days prior to enrolling in this study
  • Alcohol or drug abuse or dependence within the past year as assessed by the study investigators using CAGE questionnaire and the Drug Abuse Screening Test 20 (DAST-20)
  • Are pregnant, lactating, or of child bearing potential, likely to become pregnant during the medication phase and not willing to use contraception. The following birth control measures are acceptable: approved hormonal contraceptive medications or devices, approved intra-uterine contraceptive devices, the use of two combined barrier methods (diaphragm with spermicide or condom with spermicide), birth control pills, injections, intrauterine device [IUD], abstinence, or surgical sterilization of subject or of monogamous partner.
  • Have a history of any major cardiovascular event in the past 6-months including unstable angina, acute MI or coronary angioplasty
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  • Have clinically significant acute or chronic, progressive or unstable neurologic (dementia, delirium or seizure disorder), hepatic, renal, cardiovascular, respiratory or metabolic disease that would limit participation in the study
  • Are currently on the following prescribed medications known to interact with methylphenidate and not able to stop the medication during the study period: stimulants, warfarin, anticonvulsants, antidepressants, antipsychotics, monoamine oxidase inhibitors, clonidine, theophylline and pseudo-ephedrine
  • Uncontrolled hypertension (>160/100) or tachycardia (Heart rate >110)
  • Have another house-hold member or relative participating in the study
  • Have known allergy to methylphenidate or its constituents
  • Have a specific medical condition where use of methylphenidate is contraindicated: narrow angle glaucoma, motor tics, family history or diagnosis of Tourette's syndrome, and history of GI obstruction (including history of strictures, adhesions, or abdominal surgery)
  • have an ECG with significant arrhythmias or abnormal conduction, which in the opinion of the physician investigator preclude participating in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Efficacy of Methylphenidate for Treating Tobacco Dependence

Cigarette smoking continues to be a major public health problem. Tobacco dependence interventions, as recommended by the USPHS Clinical Practice Guideline are not effective for all smokers. A need exists for new medications to treat various aspects of tobacco dependence, such as the reinforcing effects of nicotine, relief of nicotine withdrawal symptoms and prevention of early relapse. The neurobiology of the effect of methylphenidate is similar to that of the reinforcing effects of nicotine. In a small previous study, methylphenidate was reported to improve nicotine withdrawal symptoms and short term quit rates. Methylphenidate is well tolerated, has low abuse potential, and is less expensive compared to other tobacco dependence interventions. ConcertaTM, a long acting preparation of methylphenidate, is administered once a day, has similar bioavailability as the generic drug administered 3 times a day and has an overall similar or improved efficacy compared to generic methylphenidate. We plan to obtain preliminary efficacy data in a randomized, placebo-controlled phase II study assessing the effect of methylphenidate in cigarette smokers for increasing 7-day point prevalence smoking abstinence at end of treatment and 7-day point prevalence and prolonged smoking abstinence at 6-months. Critical and systematic evaluations of newer, innovative, and well-tolerated treatments to help treat tobacco use and dependence will provide a wider choice of therapeutic agents to smokers wishing to become abstinent from tobacco use.

Read the detailed description

Once enrolled in study, the subject will be put in one of 2 groups by chance (as in the flip of a coin). They will either receive methylphenidate or a placebo. Everyone in study will receive nicotine dependence counseling based on the intervention manual "Smoke Free and Living It". Everyone will be asked to complete weekly study visits for 8 weeks and one follow-up phone call at week 16 and a final study visit at week 24. The target quit day is the day after visit 4 (week 2 + 1 day). In the first two weeks after starting study medication they will slowly build up to 3 pills a day. For weeks 2 through 8 they will continue to take 3 pills a day.

Conditions
Smoking
Being tested
Methylphenidate, Placebo
Keywords
nicotine dependence, tobacco dependence
Medical subject headings
Smoking, Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MethylphenidateDrug

    Also called Methylphenidate, Osmotic Release methylphenidate (OROS-MPH)

    54 mg Methylphenidate per day for 8 weeks. Allowing for a ramp up in the first two weeks (starting dose is 18 mg/day).

  • PlaceboDrug

    non-active (sugar pill)designed to be a look-alike to the methylphenidate. Given at the same frequency and dosage look-alike to the active comparator (methylphenidate 54 mg)

Study groups in NCT00549640
Study groupRoleWhat they receive
MethylphenidateActive comparator54 mg Methylphenidate per day for 8 weeks. Allowing for a ramp up in the first two weeks (starting dose is 18 mg/day).
Receives: Drug: Methylphenidate
PlaceboPlacebo comparatornon-active (sugar pill)designed to be a look-alike to the methylphenidate. Given at the same frequency and dosage look-alike to the active comparator (methylphenidate 54 mg)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects Biochemically Confirmed to be Abstinent From Smoking at End of Treatment.

    Number of subject who self report no smoking in the last 7 days (7-day point prevalence)at the end of the medication phase (week 8) and are biochemically confirmed (expired carbon monoxide <= 8 ppm)

    Measured: 8 weeks

  2. Number of Subjects Biochemically Confirmed to be Abstinent From Smoking at End of Study

    Number of subject who self report no smoking in the last 7 days (7-day point prevalence)at the end of study (week 24) and are biochemically confirmed (expired carbon monoxide <= 8 ppm)

    Measured: 6 months

Secondary outcomes (1)

  1. The Change in the Average Nicotine Withdrawal Symptom Score From Baseline to 14 Days Post Target Quit Date.

    The average composite nicotine withdrawal score (using Minnesota Nicotine Withdrawal Scale) change from baseline for the first 14 days following target quit date. Scale scores range from 0 (none) to 4 (severe).

    Measured: baseline and 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2007 (estimated)
  2. Study startJan 2008
  3. Primary completionJan 2009
  4. Study completionMay 2009

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00549640
Sponsor's protocol ID
06-005407
Other IDs
06-006284
Status last verified
Apr 2011
First submitted
24 Oct 2007
Last updated
19 Apr 2011
Data monitoring committee
Yes

Publications

  • Hurt RD, Ebbert JO, Croghan IT, Schroeder DR, Sood A, Hays JT. Methylphenidate for treating tobacco dependence in non-attention deficit hyperactivity disorder smokers: a pilot randomized placebo-controlled trial. J Negat Results Biomed. 2011 Jan 28;10:1. doi: 10.1186/1477-5751-10-1.

    PubMed 21276244

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Methylphenidate in people with Smoking, run by Mayo Clinic 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 5 inclusion and 13 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 19 Apr 2011. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Subjects Biochemically Confirmed to be Abstinent From Smoking at End of Treatment. (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00549640, which also lists 1 linked publication.

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 19 Apr 2011.

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Testing Methylphenidate for Smoking Abstinence | AzTrials