Treatment for Nicotine Addiction in Women

NCT02448654 | Completed Results DMC

• 2 other identifiers: 15040156281R21DA038253-01A1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to use a medication tolcapone and or placebo to test if the symptoms of nicotine withdrawal lessens , and or changes in smoking urges, and mental reasoning in female smokers over a 72 hour period.

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (3)

• Withdrawal Symptoms (MNWS Score)

  The MNWS was the 8 item version, using VAS scales for each item (1-100), and MNWS score calculated as an average of all items (range of possible scores for MWNS at each timepoint was 0-100, with higher MNWS scores at each timepoint indicating more withdrawal symptoms (worse outcome). Timepoints reflect 1.) the baseline (beginning of the trial, not yet receiving any pills, not yet being asked to abstain from smoking; calculated as average of scores from two visits: ad libitum baseline visit and pill day 1 measure which was collected prior to administration of pills) and 2.) the abstinence period (tolcapone or placebo pill days 6-8, during the 60-hr abstinence phase; calculated as average of scores from 3 visits: pill days 6, 7, and 8). Greater increases in scores (increases in withdrawal symptoms) during abstinence period compared to baseline reflects a worse outcome; reduced or stable scores (decreases or a lack of increases in withdrawal symptoms) during the abstinence period compa

  Baseline (ad libitum baseline and pill day 1 (pre-pill)); Abstinent Period (pill days 6, 7, 8)

• Smoking Urges (BQSU Factor 1)

  The Brief Questionnaire on Smoking Urges (BQSU) is a 10 item scale. Factor 1 reflects the urge to smoke for its rewarding properties. Factor 1 is calculated as the sum of five items (items 1, 3, 6, 7, 10), with each item score ranging from 1-7, so Factor 1 scores range from 5-35. Higher scores reflect higher smoking urges and represent a worse outcome. Timepoints reflect 1.) baseline (beginning of trial, not yet receiving pills, not yet abstaining from smoking; calculated as average of scores from ad libitum baseline visit and pill day 1 which was collected prior to administration of pills) and 2.) abstinence period (pill days 6-8, during 60-hr abstinence phase; calculated as average of scores from pill days 6, 7, and 8). Greater increases in scores (increases in smoking urges) during abstinence period compared to baseline reflects a worse outcome; decreases or a lack of increases in smoking urges during the abstinence period compared to baseline reflects a better outcome.

  Baseline (ad libitum baseline and pill day 1 (pre-pill)); Abstinent Period (pill days 6, 7, 8)

• Smoking Choice Paradigm: Amount Earned ($)

  The Smoking Choice Paradigm was done once at the end of the trial (Pill Day 8, at the end of the 60 hr abstinence period). Subjects are given forced choice options between 2 puffs of their own-brand cigarette vs. a token with a monetary value, spaced over a 90 minute period. The maximum amount subjects can earn from this task ranges from $0 to $7.50 (10 forced choice opportunities: smoke 2 puffs vs. earn 75 cent at each choice opportunity). Higher earnings reflect choice of the tokens over smoking, so this reflects a better outcome (i.e., reduced smoking choice).

  Pill-Day 8 (end of trial)

Study Arms (2)

Tolcapone

ACTIVE COMPARATOR

100mg tolcapone three times a day for 7 days then 100mg once a day on day 8

Drug: Sugar Pill

Sugar Pill

PLACEBO COMPARATOR

Sugar pill

Drug: Tolcapone

Interventions

Tolcapone DRUG

Tolcapone will be compared to sugar pill

Also known as: Tasmar

Sugar Pill

Sugar Pill DRUG

The sugar pill (placebo) will be compared to tolcapone

Also known as: Placebo

Tolcapone

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Must be 18yrs to 45yr old woman, read and write in English.
• Must smoke at least 5 or more cigarettes a day
• FTND score at least 4 or higher
• A CO reading of 10 or higher during screening
• Must be in good health as verified by medical history, screening exam, screen laboratory tests.

You may not qualify if:

• Excluded if using psychotropic medications, have contraindications to tolcapone use (e.g.. liver problems, allergy to tolcapone, history of no traumatic rhabdomyolysis or hyperpyrexia, confusion possibly related to medication), have other substance use disorder, are pregnant or breast feeding, have a current psychotic disorder, bipolar disorder, homicidal or suicidal ideation, have current (past month) substance use disorder, other than nicotine dependence, or are unable to fulfill the scheduled visits and procedures.

Sponsors & Collaborators

• Yale University: lead
• US Department of Veterans Affairs: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Veterans Administration Hospital

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Tolcapone; Sugars

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Elise E. DeVito, Ph.D./ Associate Research Scientist
• Organization: Yale University

elise.devito@yale.edu

203-737-4882

Study Officials

• Elise DeVito, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2015
• First Posted: May 19, 2015
• Study Start: October 23, 2015
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: November 24, 2020
• Results First Posted: September 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)