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Effects of Quitting Study A Test of Pre-clinical Findings

2016년 3월 11일 업데이트: John Hughes, University of Vermont

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.

연구 개요

상태

완전한

정황

상세 설명

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).

연구 유형

중재적

등록 (실제)

287

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • New Hampshire
      • Hanover, New Hampshire, 미국, 03755
        • Dartmouth College
    • Vermont
      • Burlington, Vermont, 미국, 05401
        • University of Vermont

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

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.

For former smokers:

  1. smoked >10 cigarettes daily for > 1 yr
  2. quit at least 1 yr ago
  3. use of cigarettes or e-cigarettes 5 or fewer times in past year
  4. no tobacco or nicotine-containing product in 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 < 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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 기초 과학
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Smokers Cease Smoking
Participants are paid to quit smoking without using any medications.
Smokers are paid to be abstinent for four weeks, and stop-smoking medications may not be used.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Responses to Effort Expenditure for Rewards Task (EEfRT) Test
기간: 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.
four weeks after quit date
Rewarding Events Scale score.
기간: four weeks after quit date
The score on our Rewarding Events scale.
four weeks after quit date

2차 결과 측정

결과 측정
측정값 설명
기간
Delayed Discounting
기간: 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.
four weeks after quit date
Self-reports of Anhedonia and Apathy
기간: 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.
four weeks after quit date

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2013년 4월 1일

기본 완료 (실제)

2015년 9월 1일

연구 완료 (실제)

2015년 9월 1일

연구 등록 날짜

최초 제출

2013년 4월 1일

QC 기준을 충족하는 최초 제출

2013년 4월 1일

처음 게시됨 (추정)

2013년 4월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 3월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 3월 11일

마지막으로 확인됨

2016년 3월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • CHRBS B11-185
  • R01DA031687 (미국 NIH 보조금/계약)

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