Assessing Neuropsychiatric Symptoms Including Depression, Anxiety, Irritability, and Suicidal Thoughts or Behavior in Subjects Quitting Smoking on Varenicline Tartrate or Placebo

Pfizer

Status and phase: Completed; Phase 4

Conditions: Smoking Cessation

Treatments: Drug: placebo; Drug: varenicline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00749944

A3051115

Details and patient eligibility

About

Study objective is to compare neuropsychiatric adverse events in subjects treated with varenicline or placebo in a controlled setting where both groups are experiencing nicotine withdrawal.

Enrollment: 110 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• smokers who smoke >10 cigarettes/day and who have at least a moderate level of addiction as measured by the Fagerstrom Test for Nicotine Dependence (score >5)

Exclusion criteria

• Any neuropsychiatric disease including depression, history of suicidal thoughts or behavior, bipolar disorder.
• Any unstable medical condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

110 participants in 2 patient groups, including a placebo group

varenicline

Experimental group

Treatment:

Drug: varenicline

placebo

Placebo Comparator group

Treatment:

Drug: placebo