SmokingNCT01824511
Effects of Quitting Study A Test of Pre-clinical Findings
A study testing Smokers cease smoking in people with Smoking, run by University of Vermont at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Smokers cease smoking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 21Show fewer
- 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
- quit at least 1 yr ago
- use of cigarettes or e-cigarettes 5 or fewer times in past year
- no tobacco or nicotine-containing product in 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 < 8 ppm at the time of consent
- no current use of prescribed psychoactive medications, including smoking cessation products.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Vermont
Burlington, Vermont, 05401
Dartmouth College
Hanover, New Hampshire, 03755
About this study
Official title: Does Smoking Cessation Increase Anhedonia? A Test of Pre-clinical Findings
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.
Read the detailed description
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).
- Conditions
- Smoking
- Being tested
- Smokers cease smoking
- Keywords
- smoking, nicotine, tobacco, anhedonia, reward, withdrawal
- Medical subject headings
- Smoking, Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smokers cease smokingBehavioural
Smokers are paid to be abstinent for four weeks, and stop-smoking medications may not be used.
| Study group | Role | What they receive |
|---|---|---|
| Smokers Cease Smoking | Experimental | Participants are paid to quit smoking without using any medications. Receives: Behavioral: Smokers cease smoking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: four weeks after quit date
Rewarding Events Scale score.
The score on our Rewarding Events scale.
Measured: four weeks after quit date
Secondary outcomes (2)
Delayed Discounting
Measures preference for immediate vs. delayed rewards by responses to several scenarios. Outcome is a statistic that describes relative preference by time to reward.
Measured: four weeks after quit date
Self-reports of Anhedonia and Apathy
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.
Measured: four weeks after quit date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, John Hughes, University of Vermont
- Investigators
- John R Hughes, MD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824511
- Sponsor's protocol ID
- CHRBS B11-185
- Other IDs
- R01DA031687
- Status last verified
- Mar 2016
- First submitted
- 1 Apr 2013
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Smoking Cessation Increase Anhedonia? A Test of Pre-clinical Findings
- ClinicalTrials.gov ID
- NCT01824511
- Acronym / sponsor ID
- CHRBS B11-185
- Conditions
- Smoking
- Keywords
- smoking, nicotine, tobacco, anhedonia, reward, withdrawal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smokers Cease Smoking | Experimental | Behavioral: Smokers cease smokingParticipants are paid to quit smoking without using any medications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
- currently smoke >10 cigarettes daily for > 1 yr
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smokers cease smokingSmokers are paid to be abstinent for four weeks, and stop-smoking medications may not be used. | Behavioural | Smokers Cease Smoking |
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.
2 secondary outcomes
Delayed Discounting
Time frame: four weeks after quit date
Self-reports of Anhedonia and Apathy
Time frame: four weeks after quit date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John R Hughes, MD principal investigator
University of Vermont
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smokers cease smoking in people with Smoking, run by University of Vermont at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responses to Effort Expenditure for Rewards Task (EEfRT) Test (time frame: four weeks after quit date). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2016.