Trial Outcomes & Findings for Pilot Study of Tolcapone in Smokers (NCT NCT01202955)

NCT ID: NCT01202955

Last Updated: 2018-09-12

Results Overview

Number of enrolled participants who complete the final study visit

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 19 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2018-09-12

Participant Flow

Participants were recruited using mass media advertising from July 2008 to April 2009.

Each participant's catechol-o-methyl transferase (COMT) genotype was determined prior to medication assignment.

Participant milestones

Measure	Tolcapone First, Then Placebo Day 1: 100mg three times per day orally Day 2 - Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally	Placebo First, Then Tolcapone Day 1: 100mg three times per day orally Day 2 - Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
Period 1: 10 Days STARTED	9	10
Period 1: 10 Days COMPLETED	9	8
Period 1: 10 Days NOT COMPLETED	0	2
Period 2: 7 Days (Wash-Out) STARTED	9	8
Period 2: 7 Days (Wash-Out) COMPLETED	9	8
Period 2: 7 Days (Wash-Out) NOT COMPLETED	0	0
Period 3: 10 Days STARTED	9	8
Period 3: 10 Days COMPLETED	9	8
Period 3: 10 Days NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Tolcapone First, Then Placebo Day 1: 100mg three times per day orally Day 2 - Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally	Placebo First, Then Tolcapone Day 1: 100mg three times per day orally Day 2 - Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
Period 1: 10 Days Withdrawal by Subject	0	2

Baseline Characteristics

Pilot Study of Tolcapone in Smokers

Baseline characteristics by cohort

Measure	Tolcapone First, Then Placebo n=9 Participants Day 1: 100mg three times per day orally Day 2 - Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally	Placebo First, Then Tolcapone n=10 Participants Day 1: 100mg three times per day orally Day 2 - Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	36.55 years STANDARD_DEVIATION 11.41 • n=5 Participants	40.5 years STANDARD_DEVIATION 11.77 • n=7 Participants	38.63 years STANDARD_DEVIATION 11.45 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	10 participants n=7 Participants	19 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Number of Participants who completed the study.

Number of enrolled participants who complete the final study visit

Outcome measures

Measure	Tolcapone First, Then Placebo n=9 Participants Day 1: 100mg three times per day orally Day 2 - Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally	Placebo First, Then Tolcapone n=10 Participants Day 1: 100mg three times per day orally Day 2 - Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
Number of Eligible Participants Enrolled Who Completed the Study.	9 Participants	8 Participants

SECONDARY outcome

Timeframe: 30 days

Population: Only participants who completed both sessions were analysed

To obtain preliminary data on the effects of Tolcapone on abstinence-induced neurocognitive deficits in abstinent smokers with differing COMT genotypes. We examined reaction time differences on the n-back task between tolcapone and placebo treatment.

Outcome measures

Measure	Tolcapone First, Then Placebo n=17 Participants Day 1: 100mg three times per day orally Day 2 - Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally	Placebo First, Then Tolcapone n=17 Participants Day 1: 100mg three times per day orally Day 2 - Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
N-back (Working Memory) Correct Reaction Time After Overnight Abstinence.	597.09 Milliseconds Standard Deviation 136.85	608.21 Milliseconds Standard Deviation 151.8

SECONDARY outcome

Timeframe: 30 days

Population: Only participants who completed both study phases were analyzed.

We wanted to examine the effects of Tolcapone on the Continuous Performance Task (attention task) after overnight abstinence as compared to placebo.

Outcome measures

Measure	Tolcapone First, Then Placebo n=17 Participants Day 1: 100mg three times per day orally Day 2 - Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally	Placebo First, Then Tolcapone n=17 Participants Day 1: 100mg three times per day orally Day 2 - Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
Correct Reaction Time During Attention Task Performance After Overnight Abstinence.	460.14 Milliseconds Standard Deviation 34.53	457.64 Milliseconds Standard Deviation 39.28

Adverse Events

Tolcapone First, Then Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo First, Then Tolcapone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Caryn Lerman

University of Pennsylvania

Phone: 215-746-7141

Email: clerman@mail.med.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place