Phase 4
N=20
Treatment of Nicotine Dependence and Acute Depression
Major Depressive Disorder · Nicotine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00186446 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Hamilton Depression Scale Score — -.5322 percentage of change in depression — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- bupropion and smoking cessation behavioral intervention (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Sep 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hamilton Depression Scale Score |
-.5322 | <.001 sig |
| PRIMARY Cessation of Smoking |
7 | — |
| PRIMARY Can Depression and Smoking Cessation be Treated Simultaneously |
9 | — |
Summary
The purpose of this study is to assess the safety and feasibility of concurrent treatment of nicotine dependence (cigarette smoking) and acute depression. Participants who meet DSM-IV criteria for both nicotine dependence and acute major depression will be given pharmacological treatment for both disorders at the same time, along with a brief behavioral intervention for smoking cessation.
Eligibility Criteria
Inclusion Criteria
- Age at least 18 at the beginning of the study
- Smoking at least 10 cigarettes a day (1/2 pack)
- Meets DSM-IV criteria for major depressive episode
Exclusion Criteria
- Currently pregnant
- Currently breastfeeding
- Currently diagnosed with a seizure disorder, liver disease, kidney disease, congestive heart failure or diabetes mellitis
- History of a seizure, seizure disorder, significant head trauma or central nervous system tumor
- Family history of seizures
- Currently using intravenous drugs
- Currently using any drugs (marijuana, alcohol, cocaine, opiates, stimulants, etc.) on a daily basis
- Currently using any over-the-counter stimulants and anorectics (diet pills)
- Currently on fluoxetine (Prozac), bupropion (Wellbutrin, Wellbutrin SR, Wellbutrin XL) or any other antidepressants, monoamine oxidase inhibitors, antipsychotics, benzodiazepines, theophylline, systemic steroids or levodopa
- Currently on NRT or bupropion (Zyban)
- Current or past diagnosis of anorexia nervosa
- Previous allergic response to fluoxetine, bupropion, or NRT
- Previous failed quit attempt using NRT and bupropion in combination
- Current suicidal ideation
- Current or past psychosis, mania/hypomania, or any other Axis I or Axis II psychiatric diagnosis other than major depression and nicotine dependence
Data sourced from ClinicalTrials.gov (NCT00186446). 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.