NCT03887429 is a Phase 2 clinical trial of SXC-2023 in Impulse Control Disorders, sponsored by Promentis Pharmaceuticals, Inc..

Who is sponsoring NCT03887429?

NCT03887429 is sponsored by Promentis Pharmaceuticals, Inc..

What drugs are being tested in NCT03887429?

Interventions in NCT03887429: SXC-2023, Placebos.

What condition does NCT03887429 study?

NCT03887429 studies Impulse Control Disorders.

Is NCT03887429 still recruiting?

NCT03887429 is currently completed. Last updated 17 July 2020.

Are results published for NCT03887429?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-07-17 · How we verify

NCT03887429

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

Restoring Cognitive Control (ReCon) in Acute Nicotine Withdrawal

Completed Phase 2 Results posted Last updated 17 July 2020

What this trial tests

Phase 2 trial testing SXC-2023 in Impulse Control Disorders in 34 participants. Completed in 9 July 2019.

Timeline

4 March 2019

Primary endpoint
2 July 2019

9 July 2019

Quick facts

Lead sponsor	Promentis Pharmaceuticals, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	34
Start date	4 March 2019
Primary completion	2 July 2019
Estimated completion	9 July 2019
Sites	2 locations across United States

Drugs / interventions tested

SXC-2023 — full drug profile →
Placebos — full drug profile →

Conditions studied

Impulse Control Disorders — all drugs for Impulse Control Disorders →

Sponsor

Promentis Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 25 to 55, any sex, with Impulse Control Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Safety and Tolerability of SXC-2023. Primary · Up to 5 days

Endpoint assessed using the frequency of serious adverse events, adverse events leading to discontinuation, and adverse events judged to be related to study medication.

SAEs

Group	Value	95% CI
During 200 mg SXC-2023 Treatment	0
During 800 mg SXC-2023 Treatment	0
During Placebo Treatment	0

AEs leading to study discontinuation

Group	Value	95% CI
During 200 mg SXC-2023 Treatment	0
During 800 mg SXC-2023 Treatment	0
During Placebo Treatment	0

AEs judged to be related to study drug.

Group	Value	95% CI
During 200 mg SXC-2023 Treatment	3
During 800 mg SXC-2023 Treatment	1
During Placebo Treatment	12

Activity of SXC-2023 on Impulsivity, Measured Using Stop Signal Task. Primary · 5 days

Stop Signal Reaction Time (SSRT) assesses the length of reaction time between a 'go' stimulus and a 'stop' stimulus at which the subject is able to inhibit their motor response 50% of the time. The scale is from 0-1500 milliseconds with a lower value showing reduced motor impulsivity. Subject scores were collected pre-dose on day 1 of treatment and post-dose on day 5 of treatment, and the change in subject scores was assessed.

Group	Value	95% CI
SXC-2023 200mg	4.6901	± 6.7368
SXC-2023 800mg	-1.757	± 6.8491
Placebo	3.956	± 3.9661

Activity of SXC-2023 on Risk Taking Behavior, as Measured Using Cambridge Gamblers Task - Delay Aversion Total. Primary · 5 days

Cambridge Gamblers Task measures risk taking behavior using a score from -1 to 1, with a higher value showing increased impulsivity. Subject scores were collected pre-dose on day 1 of treatment and post-dose on day 5 of treatment and change in score assessed.

Group	Value	95% CI
SXC-2023 200mg	.03236	± .02652
SXC-2023 800mg	.01358	± .02655
Placebo	.03931	± .01569

Activity of SXC-2023 on Abstinence Induced Mood, Assessed by Positive and Negative Affect Schedule. Primary · Up to 5 days.

Outcome to be measured using two scores ranging from 10-50, with a higher score indicating a more positive affect, and a lower score indicating a more negative affect. Subject scores were collected pre-dose on day 1 of treatment and post-dose on day 5 of treatment.

SXC-2023 Change in Positive Aspect

Group	Value	95% CI
200 mg SXC-2023 or Placebo QD	3.5	± 8.2
800 mg SXC-2023 or Placebo QD	2.1	± 7.0

Placebo Change in Positive Aspect

Group	Value	95% CI
200 mg SXC-2023 or Placebo QD	2.0	± 7.43
800 mg SXC-2023 or Placebo QD	3.3	± 6.5

SXC-2023 Change in Negative Aspect

Group	Value	95% CI
200 mg SXC-2023 or Placebo QD	-.9	± 5.01
800 mg SXC-2023 or Placebo QD	-1.2	± 2.61

Placebo Change in Negative Aspect

Group	Value	95% CI
200 mg SXC-2023 or Placebo QD	-.7	± 3.93
800 mg SXC-2023 or Placebo QD	.1	± 5.02

Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes, Assessed by Questionnaire on Smoking Urges. Primary · Up to 5 days.

Outcome to be measured using a score ranging from 10-70, with a higher score indicating a higher urge for a cigarette. Subject scores were collected pre-dose on day 1 of treatment and post-dose on day 5 of treatment.

SXC-2023 Change in Anticipation of Pleasure

Group	Value	95% CI
200 mg SXC-2023 or Placebo QD	-.3	± 1.155
800 mg SXC-2023 or Placebo QD	.64	± 1.332

Placebo change in Anticipation of Pleasure

Group	Value	95% CI
200 mg SXC-2023 or Placebo QD	-.04	± 1.1236
800 mg SXC-2023 or Placebo QD	.17	± .848

SXC-2023 change in Anticipation of Relief

Group	Value	95% CI
200 mg SXC-2023 or Placebo QD	.14	± 1.201
800 mg SXC-2023 or Placebo QD	.21	± 1.214

Placebo change in Anticipation of Relief

Group	Value	95% CI
200 mg SXC-2023 or Placebo QD	-.06	± .946
800 mg SXC-2023 or Placebo QD	.46	± .794

Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes, Assessed by Cigarette Evaluation Questionnaire. Primary · Up to 5 days.

Outcome to be measured using five scores ranging from 1-7 and corresponding to "Smoking Satisfaction," "Psychological Reward," "Aversion," "Enjoyment of Respiratory Tract Sensations" and "Craving Reduction." A higher score indicates a greater intensity of the associated sensation. Subject scores were collected pre-dose on day 1 of treatment and post-dose on day 5 of treatment.

SXC-2023 change in Satisfaction

Group	Value	95% CI
200 mg SXC-2023 or Placebo QD	.1	± 1.28
800 mg SXC-2023 or Placebo QD	.4	± .51

Placebo change in Satisfaction

Group	Value	95% CI
200 mg SXC-2023 or Placebo QD	.3	± .33
800 mg SXC-2023 or Placebo QD	-.2	± .69

SXC-2023 change in Psychological reward

Group	Value	95% CI
200 mg SXC-2023 or Placebo QD	.16	± 1.315
800 mg SXC-2023 or Placebo QD	.33	± .808

Placebo change in Psychological reward

Group	Value	95% CI
200 mg SXC-2023 or Placebo QD	.8	± .693
800 mg SXC-2023 or Placebo QD	-.2	± 1.071

SXC-2023 change in Aversion

Group	Value	95% CI
200 mg SXC-2023 or Placebo QD	.7	± 1.396
800 mg SXC-2023 or Placebo QD	0	± 0

Placebo change in Aversion

Group	Value	95% CI
200 mg SXC-2023 or Placebo QD	0	± 0
800 mg SXC-2023 or Placebo QD	.63	± .946

SXC-2023 change in Enjoyment of Sensation

Group	Value	95% CI
200 mg SXC-2023 or Placebo QD	0	± 1.58
800 mg SXC-2023 or Placebo QD	1.3	± 1.53

Placebo change in Enjoyment of Sensation

Group	Value	95% CI
200 mg SXC-2023 or Placebo QD	0	± 2
800 mg SXC-2023 or Placebo QD	.8	± .96

Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes and Mood, Assessed by Cue Reactivity and Likert Assessment. Primary · Up to 5 days.

Outcome to be measured using two scores, the first ranging from 10-70, with a higher score indicating a stronger urge to smoke, and the second score ranging from 10-80, with a higher score indicating a more positive mood. Subject scores were collected pre-dose on day 1 of treatment and post-dose on day 5 of treatment.

SXC-2023 change in Neutral Urge

Group	Value	95% CI
200 mg SXC-2023 or Placebo QD	.353	± 1.7932
800 mg SXC-2023 or Placebo QD	-.052	± 1.8934

Placebo change in Neutral Urge

Group	Value	95% CI
200 mg SXC-2023 or Placebo QD	-.142	± 1.5071
800 mg SXC-2023 or Placebo QD	-.173	± 1.5458

SXC-2023 change in Neutral Mood

Group	Value	95% CI
200 mg SXC-2023 or Placebo QD	1.058	± 1.3775
800 mg SXC-2023 or Placebo QD	1.667	± 1.6004

Placebo change in Neutral Mood

Group	Value	95% CI
200 mg SXC-2023 or Placebo QD	.602	± 1.7237
800 mg SXC-2023 or Placebo QD	1.192	± 1.476

SXC-2023 change in Positive Urge

Group	Value	95% CI
200 mg SXC-2023 or Placebo QD	.5	± 1.922
800 mg SXC-2023 or Placebo QD	.12	± 1.793

Placebo change in Positive Urge

Group	Value	95% CI
200 mg SXC-2023 or Placebo QD	-.12	± 1.543
800 mg SXC-2023 or Placebo QD	-.04	± 1.547

SXC-2023 change in Positive Mood

Group	Value	95% CI
200 mg SXC-2023 or Placebo QD	1.23	± 1.509
800 mg SXC-2023 or Placebo QD	1.35	± 2.065

Placebo change in Positive Mood

Group	Value	95% CI
200 mg SXC-2023 or Placebo QD	.73	± 1.666
800 mg SXC-2023 or Placebo QD	1.38	± 1.557

Levels of Glutathione (GSH) in Whole Blood Following 5 Days of Tobacco Abstinence. Secondary · Up to 5 days.

Levels total and/or reduced of GSH in whole blood will be collected at baseline (prior to dosing on Day 1) and after 5 days of tobacco abstinence (after dosing on Day 5). Subject scores were collected pre-dose on day 1 of treatment and post-dose on day 5 of treatment.

SXC-2023 change in GSH concentration

Group	Value	95% CI
200 mg SXC-2023 or Placebo QD	-3.45	± 23.318
800 mg SXC-2023 or Placebo QD	-20.6	± 73.23

Placebo change in GSH concentration

Group	Value	95% CI
200 mg SXC-2023 or Placebo QD	-5.13	± 21.826
800 mg SXC-2023 or Placebo QD	-5.12	± 23.587

Adverse events — posted to ClinicalTrials.gov

Time frame: 5 day treatment period, and following 9 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

During 200 mg SXC-2023 Treatment

Serious: 0/16 (0%)

Deaths: 0/16

During 800 mg SXC-2023 Treatment

Serious: 0/16 (0%)

Deaths: 0/16

During Placebo Treatment

Serious: 0/31 (0%)

Deaths: 0/31

Other adverse events (25 terms — click to expand)

Reaction	System	During 200 mg SXC-2023 Tre…	During 800 mg SXC-2023 Tre…	During Placebo Treatment
Headache	Nervous system disorders	—	—	—
Dry Mouth	Gastrointestinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Toothache	Gastrointestinal disorders	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—
Bradycardia	Cardiac disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—
Defecation Urgency	Gastrointestinal disorders	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—
Thirst	General disorders	—	—	—
Laceration	Injury, poisoning and procedural complications	—	—	—
Thermal burn	Injury, poisoning and procedural complications	—	—	—
Tooth fracture	Injury, poisoning and procedural complications	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—
Somnolence	Nervous system disorders	—	—	—
Anger	Psychiatric disorders	—	—	—
Emotional disorder	Psychiatric disorders	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—
Rash papular	Skin and subcutaneous tissue disorders	—	—	—
Rash pruritic	Skin and subcutaneous tissue disorders	—	—	—
Lacrimation increase	Eye disorders	—	—	—

Data from ClinicalTrials.gov NCT03887429 adverse events section.

Sponsor's own description

The purpose of this study is to explore the safety, tolerability and activity of SXC-2023 or placebo when dosed for 5 days in adults with tobacco use disorder who voluntarily abstain from the use of cigarettes.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of SXC-2023

Trials testing the same drug.

NCT06343532 — SXC-2023 Cocaine Interaction Study · Phase 1 · completed
NCT03797521 — A Study in Patients With Trichotillomania · Phase 2 · completed
NCT03542435 — Randomized, Double-Blind, Placebo-Controlled, MAD Study to Assess the Safety, Tolerability, and Pharmacokinetics of SXC · Phase 1 · completed
NCT03301298 — Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of SXC-2023 in Healthy Volunteers · Phase 1 · completed

Other recruiting trials for Impulse Control Disorders

Currently open trials in the same condition.

NCT06498349 — Bilateral Subthalamic Stimulation in PD Patients With Impulse Control Disorders - STIMPulseControl · NA · recruiting

Other Promentis Pharmaceuticals, Inc. trials

Trials by the same sponsor.

NCT03797521 — A Study in Patients With Trichotillomania · Phase 2 · completed
NCT03542435 — Randomized, Double-Blind, Placebo-Controlled, MAD Study to Assess the Safety, Tolerability, and Pharmacokinetics of SXC · Phase 1 · completed
NCT03301298 — Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of SXC-2023 in Healthy Volunteers · Phase 1 · completed

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 NCT03887429 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Promentis Pharmaceuticals, Inc.
Last refreshed: 17 July 2020

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/NCT03887429.

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