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Effects of Quitting Study A Test of Pre-clinical Findings

2016年3月11日 更新者: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.

調査の概要

状態

完了

条件

詳細な説明

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).

研究の種類

介入

入学 (実際)

287

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • New Hampshire
      • Hanover、New Hampshire、アメリカ、03755
        • Dartmouth College
    • Vermont
      • Burlington、Vermont、アメリカ、05401
        • University of Vermont

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:基礎科学
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Responses to Effort Expenditure for Rewards Task (EEfRT) Test
時間枠: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.
時間枠:four weeks after quit date
The score on our Rewarding Events scale.
four weeks after quit date

二次結果の測定

結果測定
メジャーの説明
時間枠
Delayed Discounting
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2013年4月1日

一次修了 (実際)

2015年9月1日

研究の完了 (実際)

2015年9月1日

試験登録日

最初に提出

2013年4月1日

QC基準を満たした最初の提出物

2013年4月1日

最初の投稿 (見積もり)

2013年4月4日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年3月14日

QC基準を満たした最後の更新が送信されました

2016年3月11日

最終確認日

2016年3月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • CHRBS B11-185
  • R01DA031687 (米国 NIH グラント/契約)

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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