Impulse Control DisordersPhase 2NCT03887429
Restoring Cognitive Control (ReCon) in Acute Nicotine Withdrawal
A Phase 2 study testing SXC-2023 in people with Impulse Control Disorders, run by Promentis Pharmaceuticals, Inc. at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Impulse Control Disorders
- What is being tested?
- SXC-2023
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Mar 2019to 9 Jul 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baylor College of Medicine
Houston, Texas, 77030
Celerion Inc.
Lincoln, Nebraska, 68502
About this study
Official title: 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.
Read the 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.
- Conditions
- Impulse Control Disorders
- Being tested
- SXC-2023, Placebos
- Keywords
- SXC-2023, Cognitive Control, Impulsivity, Delay Aversion, Top Down Processing, Behavioral Addiction
- Medical subject headings
- Disruptive, Impulse Control, and Conduct Disorders, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SXC-2023Drug
SXC-2023 oral capsules
PlacebosDrug
Matching Placebo oral capsules
| Study group | Role | What they receive |
|---|---|---|
| SXC-2023 200 mg followed by placebo | Experimental | SXC-2023 200mg dosed once daily for 5 days, followed by 9 day washout, then Placebo dosed once daily for 5 days. Receives: Drug: SXC-2023; Drug: Placebos |
| Placebo followed by SXC-2023 200 mg | Experimental | Placebo dosed once daily for 5 days, followed by 9 day washout, then SXC-2023 200mg dosed once daily for 5 days. Receives: Drug: SXC-2023; Drug: Placebos |
| SXC-2023 800 mg followed by placebo | Experimental | SXC-2023 800mg dosed once daily for 5 days, followed by 9 day washout, then Placebo dosed once daily for 5 days. Receives: Drug: SXC-2023; Drug: Placebos |
| Placebo followed by SXC-2023 800 mg | Experimental | Placebo dosed once daily for 5 days, followed by 9 day washout, then SXC-2023 800mg dosed once daily for 5 days. Receives: Drug: SXC-2023; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of SXC-2023.
Endpoint assessed using the frequency of serious adverse events, adverse events leading to discontinuation, and adverse events judged to be related to study medication.
Measured: Up to 5 days
Activity of SXC-2023 on Impulsivity, Measured Using Stop Signal Task.
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.
Measured: 5 days
Activity of SXC-2023 on Risk Taking Behavior, as Measured Using Cambridge Gamblers Task - Delay Aversion Total.
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.
Measured: 5 days
Activity of SXC-2023 on Abstinence Induced Mood, Assessed by Positive and Negative Affect Schedule.
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.
Measured: Up to 5 days.
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes, Assessed by Questionnaire on Smoking Urges.
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.
Measured: Up to 5 days.
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes, Assessed by Cigarette Evaluation Questionnaire.
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.
Measured: Up to 5 days.
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes and Mood, Assessed by Cue Reactivity and Likert Assessment.
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.
Measured: Up to 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start4 Mar 2019
- Primary completion2 Jul 2019
- Study completion9 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Impulse Control DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Promentis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion, Baylor College of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887429
- Sponsor's protocol ID
- PRO-202
- Status last verified
- Jul 2020
- First submitted
- 14 Mar 2019
- Last updated
- 17 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03887429
- Acronym / sponsor ID
- PRO-202
- Conditions
- Impulse Control Disorders
- Keywords
- SXC-2023, Cognitive Control, Impulsivity, Delay Aversion, Top Down Processing, Behavioral Addiction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Promentis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Celerion, Baylor College of Medicine
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 2 Jul 2019 (actual)
- Study completion
- 9 Jul 2019 (actual)
- First posted
- 25 Mar 2019 (actual)
- Results
- Posted 17 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SXC-2023 200 mg followed by placebo | Experimental | Drug: SXC-2023, Drug: PlacebosSXC-2023 200mg dosed once daily for 5 days, followed by 9 day washout, then Placebo dosed once daily for 5 days. |
| Placebo followed by SXC-2023 200 mg | Experimental | Drug: SXC-2023, Drug: PlacebosPlacebo dosed once daily for 5 days, followed by 9 day washout, then SXC-2023 200mg dosed once daily for 5 days. |
| SXC-2023 800 mg followed by placebo | Experimental | Drug: SXC-2023, Drug: PlacebosSXC-2023 800mg dosed once daily for 5 days, followed by 9 day washout, then Placebo dosed once daily for 5 days. |
| Placebo followed by SXC-2023 800 mg | Experimental | Drug: SXC-2023, Drug: PlacebosPlacebo dosed once daily for 5 days, followed by 9 day washout, then SXC-2023 800mg dosed once daily for 5 days. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SXC-2023SXC-2023 oral capsules | Drug | Placebo followed by SXC-2023 200 mg, Placebo followed by SXC-2023 800 mg, SXC-2023 200 mg followed by placebo, SXC-2023 800 mg followed by placebo |
| PlacebosMatching Placebo oral capsules | Drug | Placebo followed by SXC-2023 200 mg, Placebo followed by SXC-2023 800 mg, SXC-2023 200 mg followed by placebo, SXC-2023 800 mg followed by placebo |
Primary outcome
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.
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.
Activity of SXC-2023 on Risk Taking Behavior, as Measured Using Cambridge Gamblers Task - Delay Aversion Total.
Time frame: 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.
Activity of SXC-2023 on Abstinence Induced Mood, Assessed by Positive and Negative Affect Schedule.
Time frame: 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.
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes, Assessed by Questionnaire on Smoking Urges.
Time frame: 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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SXC-2023 in people with Impulse Control Disorders, run by Promentis Pharmaceuticals, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of SXC-2023. (time frame: Up to 5 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.