Naltrexone Augmentation of Nicotine Patch Therapy - 1
2 other identifiers
interventional
200
1 country
2
Brief Summary
Naltrexone Augmentation of Nicotine Patch Therapy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2000
Typical duration for phase_3
2 active sites
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
November 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 16, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedJanuary 12, 2017
September 1, 2005
September 16, 2005
January 11, 2017
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Age 18 and older
- Willingness and ability to give written consent
- Smoking 20 cigarettes per day for at least 1 year
- At least one prior attempt to stop smoking
- Baseline expired carbon-monoxide level of at least 10 ppm
- Weigh at least 100 lbs.
- English speaking
- One person per household
You may not qualify if:
- Pregnant or nursing women or women who do not use a reliable form of birth control
- Unstable cardiac disease
- History of dermatoses
- Current alcohol dependence
- Current use of opiates
- A urine drug screen that is positive for opiates
- Serious current neurologic, psychiatric or medical illness
- Chronic pain conditions necessitating opioid treatment
- Evidence of significant hepatocellular injury as evidence by SGOT or SGPT \>3 x normal or elevated bilirubin
- Current use of smokeless tobacco, pipes, cigars, nicotine gum or nicotine patch
- Patients requiring concomitant therapy with any psychotropic drug or on any drug with a psychotropic component
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Substance Abuse Treatment Unit
New Haven, Connecticut, 06519, United States
VA Connecticut Health Care System
New Haven, Connecticut, 06519, United States
Related Publications (2)
King AC, Cao D, Zhang L, O'Malley SS. Naltrexone reduction of long-term smoking cessation weight gain in women but not men: a randomized controlled trial. Biol Psychiatry. 2013 May 1;73(9):924-30. doi: 10.1016/j.biopsych.2012.09.025. Epub 2012 Nov 22.
PMID: 23177384DERIVEDO'Malley SS, Krishnan-Sarin S, McKee SA, Leeman RF, Cooney NL, Meandzija B, Wu R, Makuch RW. Dose-dependent reduction of hazardous alcohol use in a placebo-controlled trial of naltrexone for smoking cessation. Int J Neuropsychopharmacol. 2009 Jun;12(5):589-97. doi: 10.1017/S146114570800936X. Epub 2008 Sep 17.
PMID: 18796184DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie O'Malley, Ph.D.
Substance Abuse Treatment Unit
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
September 16, 2005
First Posted
September 22, 2005
Study Start
November 1, 2000
Study Completion
April 1, 2004
Last Updated
January 12, 2017
Record last verified: 2005-09