Pilot Study of Tolcapone in Smokers

NCT01202955 | Completed Phase 2 Results DMC

• 1 other identifier: 808250
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nicotine Dependence

Keywords

Smoking, Abstinence

Outcome Measures

Primary Outcomes (1)

• Number of Eligible Participants Enrolled Who Completed the Study.

  Number of enrolled participants who complete the final study visit

  30 days

Secondary Outcomes (2)

• N-back (Working Memory) Correct Reaction Time After Overnight Abstinence.

  30 days

• Correct Reaction Time During Attention Task Performance After Overnight Abstinence.

  30 days

Study Arms (2)

Tolcapone

ACTIVE COMPARATOR

Tolcapone

Drug: Tolcapone

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Tolcapone DRUG

Day 1 100mg three times per day Day 2 - Day 7 200mg three times per day Day 8 200mg twice a day Day 9 200mg once a day Day 10 100mg once a day

Also known as: Tasmar

Tolcapone

Placebo DRUG

Day 1 100mg three times per day Day 2 - Day 7 200mg three times per day Day 8 200mg twice a day Day 9 200mg once a day Day 10 100mg once a day

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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
• 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
• 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,

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Interventions

Tolcapone

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitrophenols; Phenols; Ketones; Nitro Compounds

Results Point of Contact

• Title: Dr. Caryn Lerman
• Organization: University of Pennsylvania

clerman@mail.med.upenn.edu

215-746-7141

Study Officials

• Caryn Lerman, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: September 16, 2010
• Study Start: July 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2009
• Last Updated: September 12, 2018
• Results First Posted: April 22, 2011

Record last verified: 2018-09

Locations

US (1)