CompletedPhase 2

Restoring Cognitive Control (ReCon) in Acute Nicotine Withdrawal

United States34 participantsStarted 2019-03-04

Plain-language 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.

Who can participate

Age range25 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:

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.

What they're measuring

Safety and Tolerability of SXC-2023.

Timeframe: Up to 5 days

Activity of SXC-2023 on Impulsivity, Measured Using Stop Signal Task.

Timeframe: 5 days

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

Timeframe: 5 days

Activity of SXC-2023 on Abstinence Induced Mood, Assessed by Positive and Negative Affect Schedule.

Timeframe: Up to 5 days.

Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes, Assessed by Questionnaire on Smoking Urges.

Timeframe: Up to 5 days.

Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes, Assessed by Cigarette Evaluation Questionnaire.

Timeframe: 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.

Timeframe: Up to 5 days.

Trial details

NCT IDNCT03887429

SponsorPromentis Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-07-02

Results submitted2020-06-08

View on ClinicalTrials.gov More Impulse Control Disorders trials

Who can participate

Age range25 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:

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.

What they're measuring

Safety and Tolerability of SXC-2023.

Timeframe: Up to 5 days

Activity of SXC-2023 on Impulsivity, Measured Using Stop Signal Task.

Timeframe: 5 days

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

Timeframe: 5 days

Activity of SXC-2023 on Abstinence Induced Mood, Assessed by Positive and Negative Affect Schedule.

Timeframe: Up to 5 days.

Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes, Assessed by Questionnaire on Smoking Urges.

Timeframe: Up to 5 days.

Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes, Assessed by Cigarette Evaluation Questionnaire.

Timeframe: 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.

Timeframe: Up to 5 days.