Pilot Study of Tolcapone in Smokers

Completed · Phase 2 · Has a placebo group

Conditions studied: Nicotine Dependence

In brief

The goals of this within-subject pilot study are: (1) assess the feasibility and safety of administering the Catechol-O-Methyl-Transferase (COMT) inhibitor, tolcapone, to smokers, and (2) explore whether tolcapone may reduce abstinence-induced cognitive and affective symptoms that promote relapse. A secondary exploratory goal is to assess whether these effects may be more pronounced in smokers who carry a high risk COMT genotype for smoking relapse: COMT val/val.

Key facts

Study ID

NCT01202955

Run by

University of Pennsylvania

People needed

19

Starts

2008-07-01

Expected to finish

2009-06-01

Last updated by the study team

2018-09-12

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Healthy as determined by a responsible physician, based on a medical evaluation including history, physical and psychiatric examination, laboratory tests, liver function monitoring.
• Smokers who are between 18 and 55 years of age and have an IQ greater than 90.
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions, listed in the consent form.
• Based upon self-report, subjects must smoke >10 cigarettes/day and be interested in quitting smoking in the next 6 months (i.e., treatment-seekers).
• Women of childbearing potential must consent to using a medically accepted method of birth control (e.g., condoms and spermicide, oral contraceptive, Depo-provera injection, contraceptive patch, tubal ligation).

You may not qualify if…

• Smoking Behavior
• Use of chewing tobacco or snuff
• Current enrollment or plans to enroll in another smoking cessation program in the next month
• Plan to use other nicotine substitutes or smoking cessation treatments in the next month
• Provide a baseline carbon monoxide (CO) reading < 10ppm
• Alcohol/Drug Exclusion Criteria
• History of substance abuse and/or currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana, MDMA/ecstasy, or stimulants)
• Current alcohol consumption that exceeds >14 standard drinks/week for men and >7 standard drinks/week for women over the last 6 months
• Medication Exclusion Criteria
• Current use or recent discontinuation (within last 4-weeks) of any medication including the following:
• Any form of psychotropic medications including:
• antipsychotics,
• atypical antipsychotics,
• mood-stabilizers,
• anti-depressants (tricyclics, SSRI's, MAOI's, nonselective MAOIs, Wellbutrin/Zyban),
• anti-panic agents,
• anti-obsessive agents,
• anti-anxiety agents, and
• stimulants (e.g., Provigil, Ritalin)
• Varenicline
• Medication for chronic pain
• Anti-coagulants (e.g., Warfarin)
• Any heart medications
• Daily medication for asthma
• Apomorphine, dobutamine, isoproterenol, levodopa, methyldopa, or sympathomimetic (e.g., albuterol, pseudoephedrine)

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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