- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03887429
Restoring Cognitive Control (ReCon) in Acute Nicotine Withdrawal
July 1, 2020 updated by: Promentis Pharmaceuticals, Inc.
An Exploratory, Placebo-Controlled, Crossover Study to Examine the Safety and Activity of SXC-2023 to Improve Behavioral Dynamics in Non-Treatment Seeking Adults Undergoing Acute Nicotine Withdrawal
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is a Phase 2A, randomized, double-blinded, placebo-controlled, two-period crossover study to evaluate the effect of two doses of SXC-2023 on measures of impulsivity and inhibitory control, urge for cigarettes, and mood in non-treatment seeking smokers who are abstaining from smoking.
The study consists of a screening period of up to 30 days, a 5 day randomized double-blind treatment period, a 9 day washout period, followed by a second 5 day randomized double-blind treatment period, with a safety follow-up period 7 days after the last dose of study medication.
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
Nebraska
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Lincoln, Nebraska, United States, 68502
- Celerion Inc.
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Texas
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult, female or male, 28-55 years of age, inclusive at screening.
- BMI ≥ 16.0 and ≤ 35.0 kg/m2 at screening.
- Has provided signed written informed consent and has willingness and ability to comply with all aspects of the protocol, including abstaining from the use of tobacco/nicotine products for two 5-day periods.
- Non-treatment seeking smokers regularly using tobacco with a FTND score ≥4 at screening and self-reported use of ≥10 cigarettes/day at screening.
- Has smoked for >5 years at screening.
- Meets Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for tobacco use disorder.
- Must have a score ≥ 4 on the FTND and an expired-air CO level ≥10 ppm during initial screening and prior to first dose.
For a female of childbearing potential: either be sexually inactive (abstinent as a life style) for 28 days prior to the first dosing and throughout the study or be using one of the following acceptable birth control methods:
- Oral contraceptives used for at least 3 months prior to the first dose.
- Non-hormone releasing intrauterine device for at least 3 months prior to the first dose and with either a physical (e.g., condom, diaphragm, or other) or a chemical (e.g., spermicide) barrier method from the time of screening and throughout the study.
- Double physical barrier method (e.g., condom and diaphragm) from 14 days prior to the first dose and throughout the study.
Female of non-childbearing potential: must have undergone one of the following sterilization procedures, at least 6 months prior to the first dose:
- hysteroscopic sterilization;
- bilateral tubal ligation or bilateral salpingectomy;
- hysterectomy;
- bilateral oophorectomy; Or be postmenopausal with amenorrhea for at least 1 year prior to the first dose with serum follicle stimulating hormone levels consistent with postmenopausal status or have medically documented history of biological or congenital sterility.
- Has not used Aricept 30 days prior to screening.
Exclusion Criteria:
- Subject is mentally or legally incapacitated or has significant emotional problems or clinically significant abnormality at the time of the screening visit or expected during the conduct of the study.
- Subject suffered a concussion 6 months or less prior to screening.
- Females who are pregnant or breastfeeding.
- Positive for active hepatitis, human immunodeficiency virus (HIV), coagulopathy, or hepatic illness.
- Use of Selective Serotonin or Norepinephrine Reuptake Inhibitors for psychiatric illness (e.g. depression, anxiety, etc.), unless subject has been on a stable dose for at least 30 days prior to screening.
- Use of antipsychotics or use of antiepileptics within 30 days prior to screening.
- Use of NAC within 30 days prior to screening.
- Use of Chantix or related smoking cessation medications (e.g., NicoDerm patch, Nicorette gum, etc) within 30 days prior to the first dose.
- Use of sulfasalazine (Azulfidine®) within 30 days prior to the first dose.
- DSM-5 criteria for alcohol/substance use disorder (except for tobacco use disorder).
- History or presence of clinically significant psychiatric condition (except for tobacco use disorder) or disease in the opinion of the PI or designee.
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- History of seizures.
- Any history of psychiatric hospitalization in the past year.
- Currently participating in a clinical study.
- Previously participated in any Phase 1 Promentis studies or dosed in this Phase 2A study.
- FTND score <4 and expelled CO levels <10 ppm at screening and prior to first dose.
- Any clinically significant laboratory, ECG and/or vital sign abnormalities at screening.
- Unable to read/understand/speak English.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SXC-2023 200 mg followed by placebo
SXC-2023 200mg dosed once daily for 5 days, followed by 9 day washout, then Placebo dosed once daily for 5 days.
|
SXC-2023 oral capsules
Matching Placebo oral capsules
|
Experimental: Placebo followed by SXC-2023 200 mg
Placebo dosed once daily for 5 days, followed by 9 day washout, then SXC-2023 200mg dosed once daily for 5 days.
|
SXC-2023 oral capsules
Matching Placebo oral capsules
|
Experimental: SXC-2023 800 mg followed by placebo
SXC-2023 800mg dosed once daily for 5 days, followed by 9 day washout, then Placebo dosed once daily for 5 days.
|
SXC-2023 oral capsules
Matching Placebo oral capsules
|
Experimental: Placebo followed by SXC-2023 800 mg
Placebo dosed once daily for 5 days, followed by 9 day washout, then SXC-2023 800mg dosed once daily for 5 days.
|
SXC-2023 oral capsules
Matching Placebo oral capsules
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and Tolerability of SXC-2023.
Time Frame: 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.
|
Up to 5 days
|
Activity of SXC-2023 on Impulsivity, Measured Using Stop Signal Task.
Time Frame: 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.
|
5 days
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Activity of SXC-2023 on Risk Taking Behavior, as Measured Using Cambridge Gamblers Task - Delay Aversion Total.
Time Frame: 5 days
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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.
|
5 days
|
Activity of SXC-2023 on Abstinence Induced Mood, Assessed by Positive and Negative Affect Schedule.
Time Frame: Up to 5 days.
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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.
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Up to 5 days.
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Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes, Assessed by Questionnaire on Smoking Urges.
Time Frame: Up to 5 days.
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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.
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Up to 5 days.
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Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes, Assessed by Cigarette Evaluation Questionnaire.
Time Frame: 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.
|
Up to 5 days.
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Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes and Mood, Assessed by Cue Reactivity and Likert Assessment.
Time Frame: Up to 5 days.
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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.
|
Up to 5 days.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Levels of Glutathione (GSH) in Whole Blood Following 5 Days of Tobacco Abstinence.
Time Frame: 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.
|
Up to 5 days.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 4, 2019
Primary Completion (Actual)
July 2, 2019
Study Completion (Actual)
July 9, 2019
Study Registration Dates
First Submitted
March 14, 2019
First Submitted That Met QC Criteria
March 20, 2019
First Posted (Actual)
March 25, 2019
Study Record Updates
Last Update Posted (Actual)
July 17, 2020
Last Update Submitted That Met QC Criteria
July 1, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO-202
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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