Nicotine Delivery Systems: Research & Treatment (NDS)

US Department of Veterans Affairs (VA)

Status: Terminated

Conditions: Smoking

Treatments: Other: Computer learning; Drug: Nicotine gum - 2 mg and 4 mg; Drug: Nicotine inhaler (4 mg yield) - low and high "dosage" by frequency of puffing; Drug: Nicotine lozenges - 2 mg and 4 mg

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00108342

NEUA-015-07S

Details and patient eligibility

About

The purpose of this study is to determine whether sampling nicotine replacement treatments (NRTs) is superior to learning about them by computer. Testing also covers preferences among the treatments. Subjects will be enrolled veterans who smoke.

Hypothesis: Direct experience ("sampling") of NRTs will increase knowledge about NRTs, motivation/confidence, use of NRTs and quit attempts in contrast to learning about NRTs by computer.

Full description

The study was designed to compare sampling of several nicotine replacement treatments (NRTs) in contrast to a computer learning control. The NRTs include: 2 dosages of nicotine gum, 2 dosages of nicotine lozenges and 2 dosages of oral nicotine inhalers. In the sampling group, each participant tries each of the 6 NRTs for 3 minutes. In the control, the individuals read about the treatments. Dependent measures include: quit attempts, use of NRTs, preferences among NRTs, and learning and motivation.

Enrollment: 25 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Must be enrolled veteran who smokes.

Exclusion criteria

• Any event or condition that could be exacerbated by the local effects of nicotine treatments (e.g., throat or stomach problems; any kind of wheezing from a condition or medication)
• other criteria as determined by PI and study physicians
• reactions to menthol (inhaler) or to aspartame (lozenge)

Trial design

25 participants in 2 patient groups

Nicotine Replacement Treatment (NRT) Sampling

Active Comparator group

Description:

Sampling = 3 minute testing of each of 6 NRTs (3 forms x 2 dosages) 2 mg and 4 mg nicotine gum; 2 mg and 4 mg nicotine lozenges; frequent and infrequent puffing on a nicotine inhaler (can yield 4 mg from 10 mg device).

Treatment:

Drug: Nicotine lozenges - 2 mg and 4 mg

Drug: Nicotine inhaler (4 mg yield) - low and high "dosage" by frequency of puffing

Drug: Nicotine gum - 2 mg and 4 mg

NRT Computer Learning

Sham Comparator group

Description:

Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only

Treatment:

Other: Computer learning