NCT02641028 is a Phase 2 clinical trial of CERC-501 in Smoking, sponsored by Janssen Research & Development, LLC.

Who is sponsoring NCT02641028?

NCT02641028 is sponsored by Janssen Research & Development, LLC.

What drugs are being tested in NCT02641028?

Interventions in NCT02641028: CERC-501, Placebo.

Is NCT02641028 still recruiting?

NCT02641028 is currently completed. Last updated 27 April 2025.

Last reviewed 2025-04-27 · How we verify

NCT02641028

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study in a Human Laboratory Model of Smoking Behavior

Completed Phase 2 Last updated 27 April 2025

What this trial tests

Phase 2 trial testing CERC-501 in Smoking in 71 participants. Completed in 31 December 2016.

Timeline

31 December 2015

Primary endpoint
13 September 2016

31 December 2016

Quick facts

Lead sponsor	Janssen Research & Development, LLC
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	71
Start date	31 December 2015
Primary completion	13 September 2016
Estimated completion	31 December 2016
Sites	3 locations across United States

Drugs / interventions tested

CERC-501 — full drug profile →
Placebo

Conditions studied

Smoking — all drugs for Smoking →

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

Adults 21 to 60, any sex, with Smoking. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a Human Laboratory Model of Smoking Behavior.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

A randomized, double-blind, placebo-controlled study of the kappa opioid receptor antagonist, CERC-501, in a human laboratory model of smoking behavior.
Jones JD, Babalonis S, Marcus R, Vince B, et al · · 2020 · cited 23× · PMID 31240842 · DOI 10.1111/adb.12799
KOR Control over Addiction Processing: An Exploration of the Mesolimbic Dopamine Pathway.
Estave PM, Spodnick MB, Karkhanis AN. · · 2022 · cited 20× · PMID 33301050 · DOI 10.1007/164_2020_421
Systemic kappa opioid receptor antagonism accelerates reinforcement learning via augmentation of novelty processing in male mice.
Farahbakhsh ZZ, Song K, Branthwaite HE, Erickson KR, et al · · 2023 · cited 6× · PMID 36804487 · DOI 10.1038/s41386-023-01547-x
Kappa opioid receptor control of motivated behavior revisited.
Farahbakhsh ZZ, Siciliano CA. · · 2026 · cited 1× · PMID 41083597 · DOI 10.1038/s41386-025-02226-9

Verify or expand the search:

Other trials of CERC-501

Trials testing the same drug.

NCT02800928 — Does CERC-501 Attenuate Stress-precipitated Smoking Lapse? · Phase 2 · completed
NCT01913535 — Proof-of-Concept Trial of CERC-501 Augmentation of Antidepressant Therapy in Treatment-Resistant Depression · Phase 2 · terminated

Other recruiting trials for Smoking

Currently open trials in the same condition.

NCT07488741 — Comparison of the Effects of Different Chest Techniques on University Students With Smoking Addiction · NA · recruiting
NCT07443631 — Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variants · NA · recruiting
NCT07132814 — Abuse Liability for Five Modern Oral Nicotine Products · NA · recruiting
NCT06966258 — Inspire HER: Inspiring the Heart and Emotions for Radical Health · NA · recruiting
NCT06713603 — Technology Assisted Motivational Interviewing · NA · recruiting

Other Janssen Research & Development, LLC trials

Trials by the same sponsor.

NCT07518186 — A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma · Phase 3 · not yet recruiting
NCT07309445 — A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC · recruiting
NCT07499232 — A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease · Phase 3 · not yet recruiting
NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
NCT07227025 — A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer · Phase 1, PHASE2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02641028 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Janssen Research & Development, LLC
Last refreshed: 27 April 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02641028.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing