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| Sponsor: | Mayo Clinic |
|---|---|
| Collaborator: |
Ortho-McNeil Janssen Scientific Affairs, LLC |
| Information provided by: | Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00549640 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Smoking |
Drug: Methylphenidate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Efficacy of Methylphenidate for Treating Tobacco Dependence |
| Enrollment: | 80 |
| Study Start Date: | January 2008 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| Principal Investigator: | Richard D. Hurt, M.D. | Mayo Clinic |
More Information
| Responsible Party: | Mayo Clinic ( Richard D. Hurt, M.D. ) |
| Study ID Numbers: | 06-005407, 06-006284 |
| Study First Received: | October 24, 2007 |
| Last Updated: | July 31, 2009 |
| ClinicalTrials.gov Identifier: | NCT00549640 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
nicotine dependence tobacco dependence |
|
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Tobacco Use Disorder Physiological Effects of Drugs Disorders of Environmental Origin Methylphenidate Central Nervous System Stimulants |
Pharmacologic Actions Smoking Habits Mental Disorders Therapeutic Uses Substance-Related Disorders Dopamine Agents Central Nervous System Agents |