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| ID | Type | Description | Link |
|---|---|---|---|
| R34DA042228 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study is to assess the effects of administering N-Acetylcysteine (NAC) to assist in initial cessation and/or relapse prevention in adult cigarette smokers.
The aim of this study is to assess the effects of N-acetylcysteine (NAC) on initial cessation and relapse prevention in adult cigarette smokers. Specifically, this study has the following aims: Aim 1) Examine the efficacy of NAC, compared to placebo, in helping smokers achieve three days of continuous abstinence; Aim 2) Among those who maintain initial 3-day abstinence, examine the time to relapse over the 8-week intervention between NAC and placebo groups; Aim 3) Assess 7-day point prevalence abstinence at the 8-week end-of-treatment study visit in order to obtain effect sizes and estimates of variability to power a randomized clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matched placebo will be given to half of the study participants. |
|
| N-Acetylcysteine (NAC) | Active Comparator | NAC will be given to half of the study participants. The dose of NAC will be 2400 mg per day (1200 mg taken twice per day as two 600 mg capsules) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetylcysteine (NAC) | Drug | NAC or matched placebo will be given to study participants for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Biochemically-verified Abstinence From Smoking on Days 1-3 of the Protocol. | Abstinence will be measured through biochemical verification via breath carbon monoxide. Abstinence is defined as a 75% reduction in carbon monoxide values (parts per million) from smoking baseline levels. | Days 1-3 of the study protocol |
| Measure | Description | Time Frame |
|---|---|---|
| Days to Relapse to Smoking Among Abstinent Participants | Relapse to smoking will be measured through carbon monoxide-verified relapse at weekly study visits among those who abstained during the 3-day quit attempt. Relapse (return to smoking) will be defined as carbon monoxide values (in parts per million) that do not meet abstinence criteria (i.e., 75% reduction from baseline smoking levels). | Days 4-56 of the study protocol |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29513609 | Derived | Tomko RL, Gray KM, Oppenheimer SR, Wahlquist AE, McClure EA. Using REDCap for ambulatory assessment: Implementation in a clinical trial for smoking cessation to augment in-person data collection. Am J Drug Alcohol Abuse. 2019;45(1):26-41. doi: 10.1080/00952990.2018.1437445. Epub 2018 Mar 7. |
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Following screening, participants completed mobile daily diaries leading up to a Training visit. During this visit, participants were instructed on how to leave a carbon monoxide samples, upload videos, and loaned equipment to complete remote samples. Prior to randomization, 22 participants withdrew, were lost to follow-up or were discontinued.
Adult daily cigarette smokers were recruited from the community in Charleston, South Carolina (US).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matched placebo will be given to half of the study participants. Placebo: Matched placebo (2 capsules taken in the morning and evening) will be taken by study participants for eight weeks. All participants will receive brief smoking cessation counseling and support. |
| FG001 | N-Acetylcysteine (NAC) | NAC will be given to half of the study participants. The dose of NAC will be 2400 mg per day (1200 mg taken twice per day as two 600 mg capsules) N-acetylcysteine (NAC): NAC or matched placebo will be given to study participants for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matched placebo will be given to half of the study participants. Placebo: Matched placebo (2 capsules taken in the morning and evening) will be taken by study participants for eight weeks. All participants will receive brief smoking cessation counseling and support. |
| BG001 | N-Acetylcysteine (NAC) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Biochemically-verified Abstinence From Smoking on Days 1-3 of the Protocol. | Abstinence will be measured through biochemical verification via breath carbon monoxide. Abstinence is defined as a 75% reduction in carbon monoxide values (parts per million) from smoking baseline levels. | Posted | Count of Participants | Participants | Days 1-3 of the study protocol |
|
3 months (randomization to last post-treatment follow-up visit)
Assessed and coded in MedDRA terminology by the medical clinician at each visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Matched placebo will be given to half of the study participants. Placebo: Matched placebo (2 capsules taken in the morning and evening) will be taken by study participants for eight weeks. All participants will receive brief smoking cessation counseling and support. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erin A. McClure, Ph.D. | Medical University of South Carolina | 843-792-7192 | mccluree@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2019 | Jul 31, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo | Other | Matched placebo (2 capsules taken in the morning and evening) will be taken by study participants for eight weeks. All participants will receive brief smoking cessation counseling and support. |
|
| Number of Participants With 7-day Point Prevalence Abstinence at the 8-week End-of-treatment Visit | Seven day point prevalence abstinence will be measured through biochemical verification via breath carbon monoxide and urinary cotinine analysis. Abstinence is defined as a 75% reduction in carbon monoxide values (parts per million) from smoking baseline levels and a negative urine cotinine measure (<80 ng/mL). | Days 49-56 |
NAC will be given to half of the study participants. The dose of NAC will be 2400 mg per day (1200 mg taken twice per day as two 600 mg capsules) N-acetylcysteine (NAC): NAC or matched placebo will be given to study participants for 8 weeks. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
NAC will be given to half of the study participants. The dose of NAC will be 2400 mg per day (1200 mg taken twice per day as two 600 mg capsules)
N-acetylcysteine (NAC): NAC or matched placebo will be given to study participants for 8 weeks.
|
|
| Secondary | Days to Relapse to Smoking Among Abstinent Participants | Relapse to smoking will be measured through carbon monoxide-verified relapse at weekly study visits among those who abstained during the 3-day quit attempt. Relapse (return to smoking) will be defined as carbon monoxide values (in parts per million) that do not meet abstinence criteria (i.e., 75% reduction from baseline smoking levels). | Posted | Mean | Standard Error | days | Days 4-56 of the study protocol |
|
|
|
| Secondary | Number of Participants With 7-day Point Prevalence Abstinence at the 8-week End-of-treatment Visit | Seven day point prevalence abstinence will be measured through biochemical verification via breath carbon monoxide and urinary cotinine analysis. Abstinence is defined as a 75% reduction in carbon monoxide values (parts per million) from smoking baseline levels and a negative urine cotinine measure (<80 ng/mL). | Posted | Count of Participants | Participants | Days 49-56 |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 32 |
| 55 |
| EG001 | N-Acetylcysteine (NAC) | NAC will be given to half of the study participants. The dose of NAC will be 2400 mg per day (1200 mg taken twice per day as two 600 mg capsules) N-acetylcysteine (NAC): NAC or matched placebo will be given to study participants for 8 weeks. | 0 | 59 | 0 | 59 | 33 | 59 |
| Chromaturia | Renal and urinary disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Depressed Mood | Psychiatric disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Folliculitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Hip Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hyperglycemia | Endocrine disorders | Systematic Assessment |
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| Hypertension (worsening) | Vascular disorders | Systematic Assessment |
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| Animal Bite | Injury, poisoning and procedural complications | Systematic Assessment |
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| Cardiac Flutter | Cardiac disorders | Systematic Assessment |
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| Cellulitis | Infections and infestations | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Back Pain (Worsening) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dermatitis Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
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| Influenza | Infections and infestations | Systematic Assessment |
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| Influenza Like Illness | Infections and infestations | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Oral Herpes | Infections and infestations | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Irritability | Psychiatric disorders | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | Systematic Assessment |
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| Malposition Teeth | Gastrointestinal disorders | Systematic Assessment |
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| Migraine | Nervous system disorders | Systematic Assessment |
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| Mood Swings | Psychiatric disorders | Systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Neck Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain in Jaw | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
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| Peri-umbilical Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Pharyngitis | Infections and infestations | Systematic Assessment |
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| Post Operative Pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Post Traumatic Pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Shoulder Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Sinusitis | Infections and infestations | Systematic Assessment |
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| Skin Abrasion | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Sore Throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sprained Knee | Injury, poisoning and procedural complications | Systematic Assessment |
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| Stomachache | Gastrointestinal disorders | Systematic Assessment |
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| Tachycarida | Cardiac disorders | Systematic Assessment |
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| Tooth Abscess | Infections and infestations | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
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| Viral Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
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| Vivid Dreams | Psychiatric disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |