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Effects of Quitting Study A Test of Pre-clinical Findings

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Vermont
Sponsor:
Collaborators:
Information provided by (Responsible Party):
John Hughes, University of Vermont
ClinicalTrials.gov Identifier:
NCT01824511
First received: April 1, 2013
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Smoking
Behavioral: Smokers cease smoking

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Does Smoking Cessation Increase Anhedonia? A Test of Pre-clinical Findings

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Responses to Effort Expenditure for Rewards Task (EEfRT) Test [ Time Frame: four weeks after quit date ] [ Designated as safety issue: No ]
    The primary outcome will be the percent choosing the hard task and the amount of responding for a monetary reward on the EEfRT task.

  • Rewarding Events Scale score. [ Time Frame: four weeks after quit date ] [ Designated as safety issue: No ]
    The score on our Rewarding Events scale.


Secondary Outcome Measures:
  • Delayed Discounting [ Time Frame: four weeks after quit date ] [ Designated as safety issue: No ]
    Measures preference for immediate vs. delayed rewards by responses to several scenarios. Outcome is a statistic that describes relative preference by time to reward.

  • Self-reports of Anhedonia and Apathy [ Time Frame: four weeks after quit date ] [ Designated as safety issue: No ]
    Temporal Experience of Pleasure (TEPS) and Apathy Evaluation Scale (AES) both ask participants to rate pleasantness of common rewards. Outcome is mean rating on ordinal scales. Positive and Negative Affect Scale (PANAS) and the Minnesota Nicotine Withdrawal Scale-Revised (MNWS) ask participants to rate several mood or nicotine withdrawal symptoms. Outcome is mean rating on 4 or 5 point ordinal scale.


Estimated Enrollment: 105
Study Start Date: April 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Smokers Cease Smoking
Participants are paid to quit smoking without using any medications.
Behavioral: Smokers cease smoking
Smokers are paid to be abstinent for four weeks, and stop-smoking medications may not be used.

Detailed Description:

Study design We will recruit until we have 120 current smokers who want to quit at two sites (Univ of Vermont and Dartmouth Medical School). In the first week, smokers will smoke their usual number of cigs/day. They will then quit and are to remain abstinent for 4 weeks. We will use a schedule of escalating monetary contingencies based on breath and saliva and/or urine samples to encourage abstinence. We will obtain dependent measures twice/week. The primary measures of reward responsivity will be the percent choosing the hard task and the amount of responding for a monetary reward on the EEfRT task and the score on our Rewarding Events scale. Other outcomes will be delay discounting results and self-reports of anhedonia and apathy.

The study will run for 1 week pre-cessation (2 visits) and then for 4 weeks post-cessation. Measures and biochemical verifications will occur twice/wk.

For the first week of abstinence, the cutoff for nonsmoking will be CO <8 ppm. For the remaining weeks, abstinence will be verified with a score of 0 (<10 ng/ml of cotinine) on a test strip in a saliva or urine sample plus a CO <8 ppm.

At the initial session, completion of baseline surveys will describe the sample and also measure plausible moderators such as depression.

We believe the most direct test of reward sensitivity is an evaluation of the influence of abstinence on operant responding for a reward. Thus, we have chosen performance on the Effort Expenditure for Rewards Task (EEfRT), which examines responding as a function of response cost, reward magnitude and probability of reward, as one of our primary outcomes.

For a self-report measure we will use our Rewarding Events (RE) scale that asks both about occurrence of presumed rewarding events and their anticipated pleasantness. Our RE scale will ask participants to rate 58 items on frequency in the last week as well perceived/expected pleasantness of events.

Secondary measures include the 18-item Apathy Evaluation Scale (AES), the Temporal Experience of Pleasure (TEPS), Minnesota Nicotine Withdrawal Scale-Revised (MNWS), and a measure of delay discounting (DD).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For all participants:

  • 18 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:

  1. currently smoke >10 cigarettes daily for > 1 yr
  2. want to quit smoking for good via abrupt cessation without treatment
  3. willing to quit 7-14 days from study entry and not reduce before quitting
  4. no reduction in cigs/day by >25% in the last month
  5. agree to no use of non-cigarette tobacco, non-tobacco nicotine, marijuana, illegal drugs, electronic cigarettes, or smoking cessation medications during the study
  6. have carbon monoxide (CO) level > or = 8 ppm at the time of consent
  7. no current use of prescribed psychoactive medications, including smoking cessation products.

Exclusion Criteria for all participants:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01824511

Contacts
Contact: Sharon R Muellers, BS 802 656 9626 sharon.muellers@med.uvm.edu
Contact: Dustin C Lee 603 443 1512 dustin.c.lee@dartmouth.edu

Locations
United States, New Hampshire
Dartmouth College Recruiting
Hanover, New Hampshire, United States, 03755
Contact: Alan J Budney, PhD    603-653-1821    Alan.J.Budney@dartmouth.edu   
Contact: Dustin C Lee    603 443 1512    Dustin.C.Lee@dartmouth.edu   
Principal Investigator: Alan J Budney, PhD         
United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05401
Contact: Sharon R Muellers, BS    802-656-9626    sharon.muellers@med.uvm.edu   
Contact: Sharon R Muellers    802 656 9626    Sharon.Muellers@med.uvm.edu   
Principal Investigator: John R Hughes, MD         
Sponsors and Collaborators
University of Vermont
Investigators
Principal Investigator: John R Hughes, MD University of Vermont
  More Information

No publications provided

Responsible Party: John Hughes, Principal Investigator, University of Vermont
ClinicalTrials.gov Identifier: NCT01824511     History of Changes
Other Study ID Numbers: CHRBS B11-185, R01DA031687
Study First Received: April 1, 2013
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Vermont:
smoking
nicotine
tobacco
anhedonia
reward
withdrawal

Additional relevant MeSH terms:
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014