Trials Sponsors Conditions Drugs Pricing

Conditions

Nicotine Dependence

Keywords

TobaccoSmokingSmoking CessationOutcomeNicotine Dependence

Outcome Measures

Primary Outcomes (2)

Tobacco abstinence, defined as no tobacco use by any measure (self-report, urine cotinine, and breath CO) during the assessment period.
prospective
A reduction in tobacco use of at least 50% (e.g., from 10 cigarettes per day to 5 cigarettes per day).
prospective

Secondary Outcomes (1)

Nicotine withdrawal signs and symptoms and tobacco craving (VAS) during treatment and at follow-up; duration of continuous abstinence from tobacco (self-report) and 7-day point prevalence smoking abstinence rates at follow-up time points.
prospective

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

years of age or older
Seeking help for cessation of tobacco use

You may not qualify if:

Sponsors & Collaborators

National Institute on Drug Abuse (NIDA)
NIHlead

Related Publications (3)

Allsworth JE, Weitzen S, Boardman LA. Early age at menarche and allostatic load: data from the Third National Health and Nutrition Examination Survey. Ann Epidemiol. 2005 Jul;15(6):438-44. doi: 10.1016/j.annepidem.2004.12.010.
PMID: 15967391BACKGROUND
Baker A, Lewin T, Reichler H, Clancy R, Carr V, Garrett R, Sly K, Devir H, Terry M. Motivational interviewing among psychiatric in-patients with substance use disorders. Acta Psychiatr Scand. 2002 Sep;106(3):233-40. doi: 10.1034/j.1600-0447.2002.01118.x.
PMID: 12197863BACKGROUND

MeSH Terms

Conditions

Tobacco Use DisorderSmokingSmoking Cessation

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehaviorHealth Behavior

Study Officials

Carol Myers, Ph.D.
National Institute on Drug Abuse (NIDA)
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Time Perspective: PROSPECTIVE
Sponsor Type: NIH
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 17, 2013

First Posted

May 21, 2013

Study Start

April 27, 2013

Date type not reported

This date has not been verified as actual or estimated.

Inability to give informed consent.
Current use (within the past 30 days) of any of the 7 FDA-approved first-line smoking-cessation treatments (varenicline, bupropion, or NRTs such as a nicotine inhaler, lozenge, patch, gum, or nasal spray), unless administered as part of another NIDA IRP protocol.
Any newly diagnosed or untreated acute medical illness that requires immediate medical attention. This includes any new medical diagnosis (for example, diabetes or hypertension) in someone who is not under the care of a physician and/or that is not well controlled. An untreated acute medical illness would include acute hepatitis, acute pancreatitis, acute respiratory distress syndrome, etc. Individuals may be considered for participation once a newly diagnosed condition is well controlled or an acute condition has resolved.
Current major medical conditions that in the view of the investigators would compromise the integrity of the data or the safety of the participant, including moderate to severe cardiovascular disease (30 days post-MI, severe or worsening angina pectoris), life-threatening arrhythmias, acute phase cerebrovascular accident, COPD (emphysema and chronic bronchitis).
Pregnancy
Lab values outside of the values listed in Table 1 below.
Nicotine patch only: allergy to adhesive tape, generalized chronic dermatological disorders, weight \<45kg, and/or lactation
Pregnancy or nursing
Current diagnosis of schizophrenia or any other DSM-IV psychotic disorder, bipolar disorder, panic disorder, eating disorder (current or prior diagnoses), Major Depressive Disorder within the past year requiring treatment, or history of suicide attempt
History of seizures, except for febrile seizures in childhood
Current physical dependence on alcohol or sedative-hypnotics, e.g. benzodiazepines
Lab values outside of the values listed in Table 1 below
Unstable cardiovascular disease or cardiovascular events occurring within two months before screening
For bupropion only: current administration of monoamine oxidase inhibitors (MAO-I); at least 14 days must elapse between discontinuation of an MAO-I and initiation of treatment with bupropion; current administration (within past 30 days) Wellbutrin, Wellbutrin SR, Wellbutrin XL.

Tobacco Cessation: Treatment Delivery and Predictors of Outcome

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Related Publications (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Related Publications (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record