Test of Novel Drug for Smoking Cessation

NCT02217527 | Completed Phase 2 Results DMC

• 2 other identifiers: UH3-PRO14070319UH3TR000958
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The study will assess a novel active drug vs. placebo on ability to reduce smoking and aid cessation during a one-week "practice" quit period for each condition in smokers with a high interest in quitting (i.e. crossover design). Medication effects on reducing withdrawal and cognitive impairment will help assess the mechanism to support quit smoking attempts.

Conditions

Smoking Cessation

Keywords

crossover

Outcome Measures

Primary Outcomes (1)

• Quit Status

  Complete abstinence from smoking for 24 hr is counted as a "quit day" and is assessed daily from Mon-Fri for just one week, on the JNJ active drug and one week on placebo. This same Mon-Fri procedure for one week (only) is done for both drug phases. Total outcome in each drug condition therefore is number of quit days out of the five assessment days (range 0-5).

  up to one week each drug phase (0-5)

Secondary Outcomes (2)

• Minnesota Nicotine Withdrawal Scale (MNWS) During Attempt to Quit on Active JNJ Drug and on Placebo

  only on days quit while on JNJ or on placebo

• Cognitive Function on Continuous Performance Task (CPT) for Those With CO<10 During First Assessment Day (Mon) of Attempt to Quit Smoking During Both JNJ and Plac Quit Periods

  first day during quit week on JNJ, and during quit week on placebo.

Study Arms (2)

JNJ Active Drug

EXPERIMENTAL

200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design. This JNJ experimental compound has NO name, just a company number.

Drug: Active JNJ Drug; Drug: Placebo pill

Placebo Pill

EXPERIMENTAL

Placebo pill used for one week quit attempt, as part of crossover design.

Drug: Active JNJ Drug; Drug: Placebo pill

Interventions

Active JNJ Drug DRUG

200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week.

Also known as: JNJ-39393406

JNJ Active Drug; Placebo Pill

Placebo pill DRUG

Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week.

JNJ Active Drug; Placebo Pill

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and female dependent smokers wanting to quit soon

You may not qualify if:

• Use of non-smoked nicotine products
• Already enrolled in cessation program.
• Recent alcohol or substance dependence (≤ 3 months)
• Women who are pregnant, planning a pregnancy, or lactating; all female participants shall undergo a pregnancy test at screening and will be excluded if positive.
• Serious or unstable medical disorder within the past 3 months
• Epilepsy
• Current diagnosis (within last 6-months) of abnormal cardiac rhythms; unstable cardiovascular disease e.g. stroke, myocardial infarction in the last 6 months
• Evidence impaired liver function test (LFT)
• Evidence of kidney failure
• Any subject with a history of hematological cancers examples: leukemia, lymphoma etc.
• Any clinically significant hematological laboratory abnormality.

Sponsors & Collaborators

• Chengappa, K.N. Roy, MD: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Univ of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

JNJ-39393406

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Limitations and Caveats

Our findings could be specific to the brief duration, procedures used, and single dose tested in this cross-over study.

Results Point of Contact

• Title: Dr. Kenneth A. Perkins, Prof of Psychiatry
• Organization: Univ of Pittsburgh

perkinska@upmc.edu

412-246-5395

Study Officials

• Kenneth Perkins, PhD

  Univ of PIttsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Crossover of active JNJ vs. placebo for 2 weeks each, involving 1 week of dose run-up and 1 week of attempting to quit each day on that drug condition. A one-week washout separates these drug conditions, which are administered in counter-balanced order.

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: August 15, 2014
• Study Start: November 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: January 1, 2018
• Last Updated: August 15, 2018
• Results First Posted: August 15, 2018

Record last verified: 2018-07

Locations

US (1)