Effects of Quitting Study A Test of Pre-clinical Findings

NCT01824511 | Completed

• 2 other identifiers: CHRBS B11-185R01DA031687
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 2

Brief Summary

The most widely-accepted animal model of nicotine withdrawal states stopping nicotine makes rewarding events become less rewarding. The current study will test if this is true in humans. If we find tobacco abstinence does make rewards less rewarding, this would suggest new symptoms to add to official descriptions of nicotine withdrawal. It would also suggest we need to develop new behavioral and pharmacological interventions to correct this problem. If stopping smoking does not make rewards less rewarding, this would suggest this animal model does not apply to the human condition and we need to continue to search for an animal model of tobacco withdrawal that is relevant to smokers stopping smoking.

Conditions

Smoking

Keywords

smoking; nicotine; tobacco; anhedonia; reward; withdrawal

Outcome Measures

Primary Outcomes (2)

• Responses to Effort Expenditure for Rewards Task (EEfRT) Test

  The primary outcome will be the percent choosing the hard task and the amount of responding for a monetary reward on the EEfRT task.

  four weeks after quit date

• Rewarding Events Scale score.

  The score on our Rewarding Events scale.

  four weeks after quit date

Secondary Outcomes (2)

• Delayed Discounting

  four weeks after quit date

• Self-reports of Anhedonia and Apathy

  four weeks after quit date

Study Arms (1)

Smokers Cease Smoking

EXPERIMENTAL

Participants are paid to quit smoking without using any medications.

Behavioral: Smokers cease smoking

Interventions

Smokers cease smoking BEHAVIORAL

Smokers are paid to be abstinent for four weeks, and stop-smoking medications may not be used.

Smokers Cease Smoking

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For all participants:
• yrs old or older
• able to read and understand verbal English fluently
• citizen or resident alien
• agree to abstain from illegal drugs during the study
• For current smokers:
• currently smoke \>10 cigarettes daily for \> 1 yr
• want to quit smoking for good via abrupt cessation without treatment
• willing to quit 7-14 days from study entry and not reduce before quitting
• no reduction in cigs/day by \>25% in the last month
• agree to no use of non-cigarette tobacco, non-tobacco nicotine, marijuana, illegal drugs, electronic cigarettes, or smoking cessation medications during the study
• have carbon monoxide (CO) level \> or = 8 ppm at the time of consent
• no current use of prescribed psychoactive medications, including smoking cessation products.
• For former smokers:
• smoked \>10 cigarettes daily for \> 1 yr

You may not qualify if:

• History of hand or wrist problems that could be exacerbated by study participation or interferes with completion of tasks
• current (last year) mood or alcohol/drug-related psychiatric disorder or any neurological condition that could influence reward sensitivity; e.g. Parkinsonism
• used marijuana 2 or more times in the last month
• problems with the use of alcohol or illegal drugs in the last 6 months
• currently pregnant
• use of smokeless tobacco
• lacking the use of one or both hands

Sponsors & Collaborators

• University of Vermont: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Dartmouth College

Hanover, New Hampshire, 03755, United States

Location

University of Vermont

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Smoking; Anhedonia

Condition Hierarchy (Ancestors)

Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John R Hughes, MD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: April 4, 2013
• Study Start: April 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 14, 2016

Record last verified: 2016-03

Locations

US (2)