Nicotine Replacement and Counseling In Adolescents

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 4

Conditions: Smoking Cessation

Treatments: Behavioral: Smoking cessation counseling; Drug: Nicotine nasal spray

Study type: Interventional

Funder types: Other

Identifiers

NCT00625794

1K23RR018471 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The objective of this pilot study is to determine the feasibility and utility of using the nicotine nasal spray (NNS) in adolescent smokers who want to quit smoking.

Enrollment: 40 patients

Sex: All

Ages: 15 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Be between 15 and 18 years-old
• Smoke 5 or more cigarettes per day (cpd) for at least 6 months and want to quit smoking.

Exclusion criteria

• Adolescents who were using or had used nicotine replacement in the prior week were excluded.
• Those who used bupropion (Zyban®) within the past 30 days were also excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

1

Experimental group

Description:

8 weeks or counseling plus 6 weeks of nicotine nasal spray

Treatment:

Drug: Nicotine nasal spray

2

Active Comparator group

Description:

8 weeks or counseling only.

Treatment:

Behavioral: Smoking cessation counseling