Phase 4
Completed N=8,144
Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
Source: ClinicalTrials.gov NCT01456936 ↗Enrolled (actual)
8,144
Serious AEs
2.2%
Results posted
May 2016
Primary outcomePrimary: Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint — 1.3; 2.2; 2.5; 2.4 percentage of participants — p=0.0652
◆ Published Evidence
Established
26citations · ~7 / year
The effects of varenicline, bupropion, nicotine patch, and placebo on smoking cessation among smokers with major depression: A randomized clinical trial.
Summary
This study is being conducted to assess varenicline and bupropion as aids to smoking cessation treatment in subjects with and without an established diagnosis of major psychiatric disorder and to characterize the neuropsychiatric safety profile (pre-specified adverse events (AEs) in both of these populations).
Linked Publications (5)
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The effects of varenicline, bupropion, nicotine patch, and placebo on smoking cessation among smokers with major depression: A randomized clinical trial.
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Frequently Reported Adverse Events With Smoking Cessation Medications: Post Hoc Analysis of a Randomized Trial.
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Medication-assisted quit rates in participants with smoking-related diseases in EAGLES: Post hoc analyses of a double-blind, randomized, placebo-controlled clinical trial.
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Do tobacco regulatory and economic factors influence smoking cessation outcomes? A post-hoc analysis of the multinational EAGLES randomised controlled trial.
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In Reply: Changing the Culture of Tobacco Dependence Treatment Among Not Only Patients, But Also Prescribers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint |
1.3; 2.2; 2.5; 2.4; 6.5; 6.7 | 0.0652 |
| PRIMARY Estimated NPS AE Rate (%), by Cohort |
1.25; 2.44; 2.31; 2.52; 6.42; 6.62 | — |
| SECONDARY Occurrence of the Components of the NPS AE Primary Endpoint, Non-psychiatric History Cohort |
0; 1; 0; 3; 1; 0 | — |
| SECONDARY Occurrence of the Components of the NPS AE Primary Endpoint, Psychiatric History Cohort |
5; 4; 6; 2; 6; 4 | — |
| SECONDARY Occurrence of the Components of NPS AE Primary Endpoint (Overall) |
5; 5; 6; 5; 7; 4 | — |
| SECONDARY Occurrence of Severe-only NPS AEs in the Primary Endpoint, by Cohort |
0.1; 0.4; 0.3; 0.5; 1.4; 1.4 | — |
| SECONDARY Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Non-psychiatric History Cohort |
0; 1; 0; 3; 1; 0 | — |
| SECONDARY Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Psychiatric History Cohort |
5; 4; 6; 2; 6; 4 | — |
| SECONDARY Occurrence of the Components of Severe-only NPS AE Endpoint (Overall) |
5; 5; 6; 5; 7; 4 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) Total Score, Non-psychiatric History Cohort |
3.26; 3.58; 3.06; 3.38; 2.91; 3.07 | — |
| SECONDARY HADS Total Score, Psychiatric History Cohort |
6.76; 7.58; 6.82; 6.70; 6.42; 6.99 | — |
| SECONDARY HADS Total Score (Overall) |
5.03; 5.61; 4.95; 5.05; 4.68; 5.06 | — |
| SECONDARY Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Non-psychiatric History Cohort |
6; 9; 7; 6; 48; 43 | — |
| SECONDARY Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Psychiatric History Cohort |
137; 143; 111; 123; 338; 357 | — |
| SECONDARY Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Overall |
143; 152; 118; 129; 386; 400 | — |
| SECONDARY Clinical Global Impression of Improvement (CGI-I), "No Change" Rating by Visit |
94.2; 93.2; 94.6; 95.1; 90.8; 90.8 | — |
| SECONDARY CO-Confirmed Continuous Abstinence for Weeks 9 Through 12, Non-psychiatric History Cohort |
38.0; 26.1; 26.4; 13.7 | <0.0001 sig |
| SECONDARY CO-Confirmed Continuous Abstinence for Weeks 9 Through 12, Psychiatric History Cohort |
29.2; 19.3; 20.4; 11.4 | <0.0001 sig |
| SECONDARY CO-Confirmed Continuous Abstinence for Weeks 9 Through 12 (Overall) |
33.5; 22.6; 23.4; 12.5 | <0.0001 sig |
| SECONDARY CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Non-psychiatric History Cohort |
25.5; 18.8; 18.5; 10.5 | <0.0001 sig |
| SECONDARY CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Psychiatric History Cohort |
18.3; 13.7; 13.0; 8.3 | <0.0001 sig |
| SECONDARY CO-confirmed Continuous Abstinence From Week 9 Through Week 24 (Overall) |
21.8; 16.2; 15.7; 9.4 | <0.0001 sig |
| SECONDARY 7-Day Point Prevalence of Abstinence, Non-psychiatric History Cohort |
1.7; 1.0; 1.2; 1.5; 20.9; 21.3 | — |
| SECONDARY 7-Day Point Prevalence of Abstinence, Psychiatric History Cohort |
1.0; 1.2; 0.7; 0.5; 16.8; 14.6 | — |
| SECONDARY 7-Day Point Prevalence of Abstinence (Overall) |
1.3; 1.1; 0.9; 1.0; 18.8; 17.9 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female cigarette smokers, 18- 75 years, motivated to stop smoking and considered suitable for a smoking cessation attempt.
- Smoked an average of at least 10 cigarettes per day during past year and during the month prior to the screening visit, and exhaled carbon monoxide (CO) >10 ppm at screening.
- For Neuropsychiatric cohort- subjects must have proper diagnosis as outlined in protocol.
Exclusion Criteria
- Subjects with a past or current diagnosis of one of the following disorders:
a. Psychotic Disorders:
- Schizophreniform
- Delusional Disorder
- Psychotic Disorder NOS b. All Delirium, Dementia, and Amnestic and Other Cognitive Disorders c. All Substance Induced Disorders (Other than nicotine)
Data sourced from ClinicalTrials.gov (NCT01456936) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.