Smoking Cessation Study In Healthy Adolescent Smokers

Pfizer

Status and phase: Completed; Phase 4

Conditions: Smoking Cessation

Treatments: Drug: Placebo; Drug: Varenicline 1mg BID; Drug: Varenicline 0.5mg BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT01312909

CHANTIX (Other Identifier)

A3051073

Details and patient eligibility

About

The study is designed to see if varenicline combined with age appropriate (adolescent) smoking cessation counseling will help teens quit smoking.

Enrollment: 312 patients

Sex: All

Ages: 12 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy male and female subjects between the ages of 12 and 19, inclusive.
• Subjects smoking at least an average of 5 cigarettes per day, motivated to stop smoking,
• Subjects must have at least one prior failed attempt to quit smoking.

Exclusion criteria

• Subjects with history, current diagnosis, or treatment of major depression disorder, anxiety disorders, panic disorder, hostility or aggression disorder, perceptual/thinking disturbances, mania, psychosis, bipolar disorder, personality disorder, eating disorder or severe emotional problems (in the past year).
• Subjects with a prior suicide attempt: subjects hospitalized within the past 12 months due to suicidal ideation or suicidal behavior; subjects considered to have serious suicidal ideation or suicidal behavior in the past 12 months; active suicidal ideation or behavior identified at the screening or baseline visit.
• Evidence of alcohol and substance abuse/dependence (other than nicotine) within 3 months prior to screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

312 participants in 3 patient groups, including a placebo group

Varenicline 1mg BID

Experimental group

Description:

Oral Varenicline 1mg BID, or 1/2 that dose (0.5mg BID) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52

Treatment:

Drug: Varenicline 1mg BID

Varenicline 0.5mg BID

Experimental group

Description:

Oral Varenicline 0.5mg BID, or 1/2 that dose (0.5 QD) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52

Treatment:

Drug: Varenicline 0.5mg BID

Placebo

Placebo Comparator group

Description:

Oral placebo for twelve weeks,follow-up through Week 52

Treatment:

Drug: Placebo