Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006151
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
2000-08-08
Brief Title:
Combining a Smoke Ending Aid With Behavioral Treatment - 1
Sponsor:
Peter Gariti
Organization:
University of Pennsylvania
Study Overview
Official Title:
Combining a Smoke Ending Aid With Behavioral Treatment
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to combine a smoke ending aid with behavioral treatment
Detailed Description:
The prime objective of this Innovative Stage I AB Behavioral Therapy Development Research project is to conduct a pilot study under randomized double-blind placebo controlled conditions to provide preliminary estimation of the efficacy of a 6 week Accu Drop nicotine fading protocol used in conjunction with cigarette tapering to bring about termination of cigarette usage in moderate to heavy smokers 15 cpd who are interested in smoking cessation Both the experimental and control groups in this study will receive six weeks of the manually driven behavioral treatment by experienced and trained therapists The experimental group N30 will also be prescribed active Accu Drops ADC while the control condition N30 will be prescribed placebo Accu Drops PDC very similar in appearance viscosity and taste to active Accu Drops Completion of the study protocol and smoking cessation rates at 1 week 1 month and 6 months post-treatment will be the prime measures of efficacy The findings of this study will provide sufficient preliminary indication for the efficacy of the experimental treatment and its extended investigation in a Phase II study or for its nonefficacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DA011645 | NIH | None | httpsreporternihgovquickSearchR01DA011645 |