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Smoking Cessation for People Living With HIV/AIDS

2021年6月30日 更新者：David Ledgerwood、Wayne State University

Behavioral Smoking Cessation Treatment for People Living With HIV/AIDS

In this proposed study with People Living with HIV/AIDS (PLWHA), we will use a stepped care model called a Sequential Multiple Assignment Randomized Trial (SMART) to examine the efficacy of low- and high-intensity smoking cessation treatments for nicotine dependent PLWHA that incorporate the current standard of care and prize-based contingency management. Intervention will be administered in a community-based HIV integrated care clinic in downtown Detroit, which has the highest prevalence rates of HIV/AIDS and smoking in Michigan. Phase 1 will last 4 weeks, and will involve brief intervention to help participants stop smoking. For phase 2, participants will be assigned to different study arms depending on whether they are Responders (reduced their smoking) or Non-responders (continued to smoke).

  1. Phase 1: We hypothesize that brief high-magnitude prize contingency management will result in greater reduction in smoking than standard of care alone.
  2. Phase 2a: We hypothesize that non-responders who are assigned to contingency management will be more likely to reduce their smoking throughout treatment and to abstain from smoking at all follow-up points.
  3. Phase 2b: We hypothesize that responders who are assigned to monitoring and low-magnitude prize contingency management will be more likely to maintain their reduced or abstinent smoking status at all follow-up time-points.

調査の概要

状態

積極的、募集していない

条件

介入・治療

詳細な説明

All research related activities will take place at the Tolan Park Medical Building located at 3901 Chrysler Service Dr, Detroit, 48201.

Participants in Phase 1 will be randomized to one of two brief interventions based on standard of care guidelines (SoC): A) brief counseling and bupropion (SoC); or B) SoC plus brief high-magnitude prize CM (HM-CM). At the end of Phase 1, participants will be classified as responders or non-responders on the basis of smoking reduction/abstinence. All participants will continue to receive bupropion. Non-responders will enter Phase 2a and be randomly assigned to: A) continued counseling and monitoring support to quit smoking (MS); or B) MS plus prize CM for abstinence (MS+CM). Phase 1 responders will be entered into Phase 2b and randomly assigned to: A) no additional treatment (NAT); or B) Continued monitoring and low intensity prize CM (LI-CM). The primary dependent variables will include cotinine and carbon monoxide (CO) levels, and longest duration of abstinence from cigarettes. Seven-day point prevalence will be used to assess outcome at post-treatment, 6-month and 12-month follow-up points.

Participants will be paid $35 for intake and $25 for each follow-up interview, which will occur at post-phase 1, post-phase 2, and 6-months and 12-months after treatment initiation. Some assessments as well as treatment sessions will be recorded to ensure data quality.

研究の種類

介入

入学 (実際)

165

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

  • アメリカ
    • Michigan
      • Detroit、Michigan、アメリカ、48201
        • Tolan Park Medical Building

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～80年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Age 18 years or older
  2. Able to read and understand English
  3. Smoke more than 10 cigarettes/day
  4. Patient enrolled in the HIV clinic with HIV or AIDS diagnosis

Exclusion Criteria:

  1. Are actively suicidal or have uncontrolled manic or psychotic symptoms requiring immediate care
  2. Are in recovery for pathological gambling (PG)
  3. Have contraindications for bupropion treatment (e.g., presence of epilepsy or other seizure disorder, use of monoamine oxidase inhibitors or other antidepressants, presence of eating disorders or very low weight)
  4. Are already participating in other smoking cessation interventions.

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：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • 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：Phase 1: Standard of Care (A)
Brief counseling and bupropion
薬：Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
他の名前：
  • ウェルブトリン
  • ザイバン
  • ブプロピオン塩酸塩
行動：Brief Counseling
Participants are provided with brief counseling for smoking cessation.
実験的：Phase 1: Standard of Care (B)
Brief counseling, bupropion, and brief high-magnitude prize contingency management.
薬：Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
他の名前：
  • ウェルブトリン
  • ザイバン
  • ブプロピオン塩酸塩
行動：Brief Counseling
Participants are provided with brief counseling for smoking cessation.
行動：High-magnitude prize contingency management
Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking.
実験的：Phase 2a Non-Responders (A)
Bupropion, continued counseling, monitored support to quit smoking.
薬：Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
他の名前：
  • ウェルブトリン
  • ザイバン
  • ブプロピオン塩酸塩
行動：Brief Counseling
Participants are provided with brief counseling for smoking cessation.
行動：Monitored support to quit smoking
Brief supportive sessions and monitoring of smoking cessation efforts.
実験的：Phase 2a: Non-Responders (B)
Bupropion, monitored support to quit smoking, prize contingency management for abstinence.
薬：Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
他の名前：
  • ウェルブトリン
  • ザイバン
  • ブプロピオン塩酸塩
行動：Monitored support to quit smoking
Brief supportive sessions and monitoring of smoking cessation efforts.
行動：Prize contingency management for abstinence
Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking.
実験的：Phase 2b: Responders (A)
Bupropion, no additional treatment.
薬：Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
他の名前：
  • ウェルブトリン
  • ザイバン
  • ブプロピオン塩酸塩
行動：No additional treatment
No additional treatment will be given.
実験的：Phase 2b: Responders (B)
Bupropion, continued monitoring and low intensity prize contingency management.
薬：Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
他の名前：
  • ウェルブトリン
  • ザイバン
  • ブプロピオン塩酸塩
行動：Monitored support to quit smoking
Brief supportive sessions and monitoring of smoking cessation efforts.
行動：Low intensity prize contingency management
Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking.

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
Urinary Cotinine
時間枠：Change from baseline: weekly in treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group); Follow-up interviews (Post-phase 1, Post-phase 2, 6-months and 12-months)
Urinary cotinine is a metabolite of nicotine, and can be detected in urine. The presence of cotinine in urine shows recent cigarette smoking. Cotinine is measured using an instant test that give a score from 0 to 6 on a semi-quantitative scale. Declining scores show an individual has stopped or significantly reduced their smoking.
Change from baseline: weekly in treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group); Follow-up interviews (Post-phase 1, Post-phase 2, 6-months and 12-months)
Longest Duration of Continuous Abstinence
時間枠：Change from baseline: Weekly through treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group)
This is the longest period of consecutive days during treatment where the participant has not smoked. Longest duration of abstinence is calculated through self-report of smoking abstinence verified by scores on biological measures (negative scores on carbon monoxide or urinary cotinine tests).
Change from baseline: Weekly through treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group)
Seven-Day Point-Prevalence
時間枠：Follow-up interviews: Post-phase 1, Post-phase 2, 6-months and 12-months after treatment initiation.
At each follow-up assessment, participants will be asked if they had smoked in the preceding seven days. They will also participate in cotinine and carbon monoxide testing. Negative scores are given when the participant reports no smoking and all tests are negative.
Follow-up interviews: Post-phase 1, Post-phase 2, 6-months and 12-months after treatment initiation.
Carbon Monoxide Results
時間枠：Change from baseline: weekly in treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group); Follow-up interviews (Post-phase 1, Post-phase 2, 6-months and 12-months)
Participants will provide breath carbon monoxide samples at each visit by blowing into a hand-held carbon monoxide reader. Carbon monoxide is produced when substances (such as cigarettes) are burned. Thus this test can show if an individual has been smoking recently.
Change from baseline: weekly in treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group); Follow-up interviews (Post-phase 1, Post-phase 2, 6-months and 12-months)

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。

スポンサー

Wayne State University

協力者

National Institute on Drug Abuse (NIDA)

捜査官

  • 主任研究者：David Ledgerwood, PhD、Wayne State University

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 (実際)

2013年8月1日

一次修了 (予想される)

2021年12月1日

研究の完了 (予想される)

2021年12月1日

試験登録日

最初に提出

2013年10月8日

QC基準を満たした最初の提出物

2013年10月15日

最初の投稿 (見積もり)

2013年10月18日

学習記録の更新

投稿された最後の更新 (実際)

2021年7月2日

QC基準を満たした最後の更新が送信されました

2021年6月30日

最終確認日

2021年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 1R01DA034537-01A1 (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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Bupropionの臨床試験

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条件

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