Combining a Smoke Ending Aid With Behavioral Treatment - 1
2 other identifiers
interventional
60
1 country
1
Brief Summary
The purpose of this study is to combine a smoke ending aid with behavioral treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 1999
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 1999
CompletedFirst Submitted
Initial submission to the registry
August 8, 2000
CompletedFirst Posted
Study publicly available on registry
August 9, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2002
CompletedResults Posted
Study results publicly available
January 6, 2014
CompletedDecember 3, 2015
December 1, 2015
2.8 years
August 8, 2000
June 24, 2013
December 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Abstinence Rate
The main outcome measures were rates of treatment completion and smoking abstinence. It was hypothesized that the nicotine blocking agent product would lead to higher treatment completion rates, higher abstinence rates, and fewer problems with withdrawal than the placebo group.
1 year
Study Arms (2)
Accu Drops (AD&C)
EXPERIMENTALThe experimental group (N=30) will be prescribed active Accu Drops (AD\&C) plus behavioral therapy.
Placebo
PLACEBO COMPARATORThe control condition (N=30) will be prescribed placebo Accu Drops (PD\&C) plus behavioral therapy.
Interventions
Weekly behavioral therapy based on Project Match Motivational Therapy clinical manual plus systematic cigarette tapering.
Eligibility Criteria
You may qualify if:
- years of age or older, and no greater than 65 years of age
- Medically stable
- Smoke at least 15 filtered cigarettes daily
- Motivated to quit smoking
You may not qualify if:
- Medically unstable
- Currently psychiatrically unstable (schizophrenia, unstable psychosis, untreated major depression, active substance abuse within the past 6 months)
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peter Garitilead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104 6178, United States
Related Publications (1)
Gariti P, Alterman AI, Lynch KG, Kampman K, Whittingham T. Adding a nicotine blocking agent to cigarette tapering. J Subst Abuse Treat. 2004 Jul;27(1):17-25. doi: 10.1016/j.jsat.2004.03.005.
PMID: 15223089BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter Gariti
- Organization
- University of Pennsylvania
Study Officials
- PRINCIPAL INVESTIGATOR
Peter W Gariti, Ph.D.
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor-Investigator
Study Record Dates
First Submitted
August 8, 2000
First Posted
August 9, 2000
Study Start
May 1, 1999
Primary Completion
February 1, 2002
Study Completion
February 1, 2002
Last Updated
December 3, 2015
Results First Posted
January 6, 2014
Record last verified: 2015-12