Test of Novel Drug for Smoking Cessation

NCT02217527 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2018-08-15

Study results available
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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

Interventions

DRUG

Active JNJ 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.

DRUG

Placebo pill

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH
  • Chengappa, K.N. Roy, MD

    lead OTHER

Principal Investigators

  • Kenneth Perkins, PhD · Univ of PIttsburgh

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2017-07-31
Completion
2018-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02217527 on ClinicalTrials.gov