Clinical Trial: Effects of Quitting Study A Test of Pre-clinical Findings

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Does Smoking Cessation Increase Anhedonia? A Test of Pre-clinical Findings

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.

Detailed Summary:

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 probab
Sponsor: University of Vermont

Current Primary Outcome:

• 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.

Original Primary Outcome:

• Responses to 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.

Current Secondary Outcome:

• 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.

Original Secondary Outcome:

• Delayed Discounted Results [ Time Frame: four weeks after quit date ]
  Delayed discounting results
• Self-reports of Anhedonia and Apathy [ Time Frame: four weeks after quit date ]
  TEPS, PANAS, MNWS, AES

Dates:
Date Received: April 1, 2013
Date Started: April 2013
Date Completion:
Last Updated: March 11, 2016
Last Verified: March 2016