Effects of Quitting Study A Test of Pre-clinical Findings
|ClinicalTrials.gov Identifier: NCT01824511|
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : March 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Smoking||Behavioral: Smokers cease smoking||Not Applicable|
Study design We will recruit until we have 70 current smokers who want to quit at two sites (Univ of Vermont and Dartmouth Medical School). We will also recruit a comparison group of 70 long-time former smokers to assist in interpretation of the results. 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. Former smokers will attend once a wee for four weeks.
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||287 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Does Smoking Cessation Increase Anhedonia? A Test of Pre-clinical Findings|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
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.
- Responses to Effort Expenditure for Rewards Task (EEfRT) Test [ Time Frame: four weeks after quit date ]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 ]The score on our Rewarding Events scale.
- Delayed Discounting [ Time Frame: four weeks after quit date ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824511
|United States, New Hampshire|
|Hanover, New Hampshire, United States, 03755|
|United States, Vermont|
|University of Vermont|
|Burlington, Vermont, United States, 05401|
|Principal Investigator:||John R Hughes, MD||University of Vermont|