Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 9 for:    "Impulse Control Disorder" | "Peripheral Nervous System Agents"

Restoring Cognitive Control in Acute Nicotine Withdrawal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03887429
Recruitment Status : Completed
First Posted : March 25, 2019
Last Update Posted : July 26, 2019
Sponsor:
Collaborators:
Baylor College of Medicine
Celerion
Information provided by (Responsible Party):
Promentis Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Impulse Control Disorders Drug: SXC-2023 Drug: Placebos Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 4, 2019
Actual Primary Completion Date : July 2, 2019
Actual Study Completion Date : July 9, 2019

Arm Intervention/treatment
Experimental: SXC-2023, 200 mg
SXC-2023 200mg dosed once daily for 5 days.
Drug: SXC-2023
SXC-2023 oral capsules

Experimental: SXC-2023, 800 mg
SXC-2023 800mg dosed once daily for 5 days.
Drug: SXC-2023
SXC-2023 oral capsules

Placebo Comparator: Placebo
Matching Placebo dosed once daily for 5 days.
Drug: Placebos
Matching Placebo oral capsules




Primary Outcome Measures :
  1. Safety and tolerability of SXC-2023 assessed using the frequency of subjects with serious adverse events, adverse events leading to discontinuation, and adverse events judged to be related to study medication. [ Time Frame: Up to 5 days ]
  2. Activity of SXC-2023 on abstinence induced mood, assessed by Positive and Negative aspect 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 aspect, and a lower score indicating a more negative aspect.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. 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 and plasma will be collected at baseline (prior to dosing on Day 1) and after 5 days of tobacco abstinence (after dosing on Day 5).

  2. Effects of SXC-2023 on GSH deficits. [ Time Frame: Up to 5 days. ]
    Levels of total and/or reduced GSH in whole blood and plasma will be collected at baseline (prior to dosing on Day 1) and after 5 days of tobacco abstinence (after dosing on Day 5).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult, female or male, 28-55 years of age, inclusive at screening.
  2. BMI ≥ 16.0 and ≤ 35.0 kg/m2 at screening.
  3. 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.
  4. Non-treatment seeking smokers regularly using tobacco with a FTND score ≥4 at screening and self-reported use of ≥10 cigarettes/day at screening.
  5. Has smoked for >5 years at screening.
  6. Meets Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for tobacco use disorder.
  7. Must have a score ≥ 4 on the FTND and an expired-air CO level ≥10 ppm during initial screening and prior to first dose.
  8. 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.
  9. Female of non-childbearing potential: must have undergone one of the following sterilization procedures, at least 6 months prior to the first dose:

    1. hysteroscopic sterilization;
    2. bilateral tubal ligation or bilateral salpingectomy;
    3. hysterectomy;
    4. 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.
  10. Has not used Aricept 30 days prior to screening.

Exclusion Criteria:

  1. 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.
  2. Subject suffered a concussion 6 months or less prior to screening.
  3. Females who are pregnant or breastfeeding.
  4. Positive for active hepatitis, human immunodeficiency virus (HIV), coagulopathy, or hepatic illness.
  5. 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.
  6. Use of antipsychotics or use of antiepileptics within 30 days prior to screening.
  7. Use of NAC within 30 days prior to screening.
  8. Use of Chantix or related smoking cessation medications (e.g., NicoDerm patch, Nicorette gum, etc) within 30 days prior to the first dose.
  9. Use of sulfasalazine (Azulfidine®) within 30 days prior to the first dose.
  10. DSM-5 criteria for alcohol/substance use disorder (except for tobacco use disorder).
  11. History or presence of clinically significant psychiatric condition (except for tobacco use disorder) or disease in the opinion of the PI or designee.
  12. 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.
  13. History of seizures.
  14. Any history of psychiatric hospitalization in the past year.
  15. Currently participating in a clinical study.
  16. Previously participated in any Phase 1 Promentis studies or dosed in this Phase 2A study.
  17. FTND score <4 and expelled CO levels <10 ppm at screening and prior to first dose.
  18. Any clinically significant laboratory, ECG and/or vital sign abnormalities at screening.
  19. Unable to read/understand/speak English.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887429


Locations
Layout table for location information
United States, Nebraska
Celerion Inc.
Lincoln, Nebraska, United States, 68502
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Promentis Pharmaceuticals, Inc.
Baylor College of Medicine
Celerion
  Study Documents (Full-Text)

Documents provided by Promentis Pharmaceuticals, Inc.:

Layout table for additonal information
Responsible Party: Promentis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03887429     History of Changes
Other Study ID Numbers: PRO-202
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Promentis Pharmaceuticals, Inc.:
Promentis Pharmaceuticals
SXC-2023
Additional relevant MeSH terms:
Layout table for MeSH terms
Peripheral Nervous System Agents
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action