Behavioral Optimization for Overcoming Suboptimal Treatment Retention (BUP-BOOSTeR) (BUP-BOOSTeR)
2026年5月24日 更新者：Boston University
BUP-BOOSTeR: Behavioral Optimization for Overcoming Suboptimal Treatment Retention
Buprenorphine, a medication for opioid use disorder (MOUD), is associated with decreased opioid overdose and all-cause mortality. Treatment outcomes improve if patients remain on MOUD for at least six months, a period recommended by expert guidelines, although most studies report retention on MOUD of 50-65% at 3-6 months. Psychosocial interventions have the potential to improve MOUD treatment retention particularly when applied in combination in efficient delivery systems.
The objective of this study is to develop an effective and efficient multicomponent intervention to increase buprenorphine retention at 6 months through an optimization trial.
調査の概要
状態
まだ募集していません
条件
詳細な説明
The investigators will leverage the Multiphase Optimization STrategy (MOST) framework for developing, optimizing, and evaluating a multicomponent behavioral intervention. The impact of three psychosocial intervention components on buprenorphine treatment retention at six months will be tested by recruiting persons initiating buprenorphine from office-based addiction treatment settings and randomizing them in a balanced 2x2x2 factorial design to some combination of the following 3 intervention components:
- Behavioral-Activation (BA)-focused on increasing positive reinforcing activities and experiences to promote recovery;
- Attendance Reinforcement (AR)- incentivizing attendance at addiction clinical care visits; and
- Peer Motivational Interviewing (Peer-MI) -increasing confidence to continue buprenorphine treatment and providing social support.
All participants will receive usual care, including brief advice to continue treatment for at least 6 months.
The observed main and interaction effects for the 3 candidate psychosocial interventions will guide the selection of components to be included in an optimized intervention (the end goal of this project).
Results from this study will be twofold:
- improve the understanding of mechanisms by which psychosocial component interventions improve buprenorphine MOUD treatment retention, and
- prepare the scientific team to conduct a future randomized controlled trial of the optimized intervention package.
The long-term impact will be to establish a psychosocial intervention package that improves retention in buprenorphine treatment.
研究の種類
介入
入学 (推定)
240
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。
研究連絡先
- 名前：Michael Stein, MD
- 電話番号：(617) 638-5042
- メール：mdstein@bu.edu
研究連絡先のバックアップ
- 名前：Sally Bendiks, MPH
- 電話番号：(617) 414-3802
- メール：Sally.Bendiks@bmc.org
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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- 18 years of age or older
- Meet DSM V criteria for opioid use disorder during the past year
- Be a patient in Office Based Addiction Treatment who has initiated buprenorphine in the last 30 days AND has had no use of prescribed buprenorphine in the 7 days before the current treatment episode AND has not received long-acting injectable buprenorphine in the 6 weeks before the current treatment episodes OR Be a person within the first 30 days of release from a carceral setting who is taking any formulation of buprenorphine for their OUD and who is within their first 30 days of intake at OBAT.
- Be willing to provide informed consent, be randomized, and complete study materials
- Be able to speak and read English sufficiently to complete study intervention and procedures
- Be willing to provide the study access to their electronic medical records
- Have no plans to change Office Based Addiction Treatment clinics during the study
Exclusion Criteria:
-Be receiving hospice or other end of life medical care
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：階乗代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Behavioral Activation
Participants in this arm will receive the behavioral activation intervention.
|
Trained study interventionists will deliver the manualized BA intervention aimed at increasing meaningful and enjoyable non-substance-related activities in early recovery.
This intervention will include 12 individual sessions delivered to participants every other week for 6 months.
The BA intervention will be delivered remotely by telephone or video visit to minimize treatment burden on patients.
|
|
実験的：Attendance Reinforcement
Participants in this arm will receive the Attendance Reinforcement intervention.
|
A voucher incentive protocol will be implemented with increasing rewards based on clinical attendance at outpatient addiction treatment visits.
The timing of clinical visits will be determined by site-specific usual care practices at both sites.
Participants are expected to earn a range of payments for visit attendance according to their unique clinical schedule (which is dictated by their addiction medicine clinical team, not by research investigators).
|
|
実験的：Peer-Delivered Motivational Interviewing
Participants in this arm will receive the Peer-Delivered Motivational Interviewing Intervention.
|
Trained study peer recovery coaches will deliver a multi-session intervention aimed at increasing treatment confidence for treatment continuation and providing social support during early recovery.
The peer recovery coach will deliver brief MI (20-minute) individual sessions remotely every other week over the 6-month period (total 12 sessions).
Peer interventionists will also be informed about local recovery resources to provide navigation support individually.
PDMI will be delivered remotely by telephone or video visit.
|
|
実験的：Behavioral Activation + Attendance Reinforcement
Participants in this arm will receive the Behavioral Activation and Attendance Reinforcement interventions.
|
Trained study interventionists will deliver the manualized BA intervention aimed at increasing meaningful and enjoyable non-substance-related activities in early recovery.
This intervention will include 12 individual sessions delivered to participants every other week for 6 months.
The BA intervention will be delivered remotely by telephone or video visit to minimize treatment burden on patients.
A voucher incentive protocol will be implemented with increasing rewards based on clinical attendance at outpatient addiction treatment visits.
The timing of clinical visits will be determined by site-specific usual care practices at both sites.
Participants are expected to earn a range of payments for visit attendance according to their unique clinical schedule (which is dictated by their addiction medicine clinical team, not by research investigators).
|
|
実験的：Behavioral Activation + Peer-Delivered Motivational Interviewing
Participants in this arm will receive the Behavioral Activation and Peer-Delivered Motivational Interviewing interventions.
|
Trained study interventionists will deliver the manualized BA intervention aimed at increasing meaningful and enjoyable non-substance-related activities in early recovery.
This intervention will include 12 individual sessions delivered to participants every other week for 6 months.
The BA intervention will be delivered remotely by telephone or video visit to minimize treatment burden on patients.
Trained study peer recovery coaches will deliver a multi-session intervention aimed at increasing treatment confidence for treatment continuation and providing social support during early recovery.
The peer recovery coach will deliver brief MI (20-minute) individual sessions remotely every other week over the 6-month period (total 12 sessions).
Peer interventionists will also be informed about local recovery resources to provide navigation support individually.
PDMI will be delivered remotely by telephone or video visit.
|
|
実験的：Attendance Reinforcement + Peer-Delivered Motivational Interviewing
Participants in this arm will receive the Attendance Reinforcement and Peer-Delivered Motivational Interviewing interventions.
|
Trained study peer recovery coaches will deliver a multi-session intervention aimed at increasing treatment confidence for treatment continuation and providing social support during early recovery.
The peer recovery coach will deliver brief MI (20-minute) individual sessions remotely every other week over the 6-month period (total 12 sessions).
Peer interventionists will also be informed about local recovery resources to provide navigation support individually.
PDMI will be delivered remotely by telephone or video visit.
A voucher incentive protocol will be implemented with increasing rewards based on clinical attendance at outpatient addiction treatment visits.
The timing of clinical visits will be determined by site-specific usual care practices at both sites.
Participants are expected to earn a range of payments for visit attendance according to their unique clinical schedule (which is dictated by their addiction medicine clinical team, not by research investigators).
|
|
実験的：Behavioral Activation + Attendance Reinforcement + Peer-Delivered Motivational Interviewing
Participants in this arm will receive the Behavioral Activation, Attendance Reinforcement, and Peer-Delivered Motivational Interviewing interventions.
|
Trained study interventionists will deliver the manualized BA intervention aimed at increasing meaningful and enjoyable non-substance-related activities in early recovery.
This intervention will include 12 individual sessions delivered to participants every other week for 6 months.
The BA intervention will be delivered remotely by telephone or video visit to minimize treatment burden on patients.
Trained study peer recovery coaches will deliver a multi-session intervention aimed at increasing treatment confidence for treatment continuation and providing social support during early recovery.
The peer recovery coach will deliver brief MI (20-minute) individual sessions remotely every other week over the 6-month period (total 12 sessions).
Peer interventionists will also be informed about local recovery resources to provide navigation support individually.
PDMI will be delivered remotely by telephone or video visit.
A voucher incentive protocol will be implemented with increasing rewards based on clinical attendance at outpatient addiction treatment visits.
The timing of clinical visits will be determined by site-specific usual care practices at both sites.
Participants are expected to earn a range of payments for visit attendance according to their unique clinical schedule (which is dictated by their addiction medicine clinical team, not by research investigators).
|
|
介入なし：Treatment As Usual
Participants randomized to this arm will receive usual care at their office based addiction treatment facility.
|
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 |
|---|---|---|
|
Number of participants with buprenorphine retention
時間枠：6 months
|
Buprenorphine retention will be defined as any of the following: 1) EHR confirmation of a prescription whose end date extends beyond the day of the 6-month assessment OR long-acting injectable buprenorphine (LAIB) administration within the last 4 weeks (for monthly Sublocade or Brixadi) or within the last 7 days (for weekly Brixadi); 2) Self-report of an active buprenorphine prescription or active LAIB administration (as previously defined); 3) Verification of medication including visualization of a pill bottle, film packet, or verification of a record of an LAIB administration event (by photo or video confirmation) for persons who change their care to another clinic during the study period
|
6 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
捜査官
- 主任研究者：Michael Stein, MD、BUSPH, Health Law, Policy & Management
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 (推定)
2026年9月1日
一次修了 (推定)
2029年12月1日
研究の完了 (推定)
2029年12月1日
試験登録日
最初に提出
2026年5月21日
QC基準を満たした最初の提出物
2026年5月21日
最初の投稿 (実際)
2026年5月26日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月28日
QC基準を満たした最後の更新が送信されました
2026年5月24日
最終確認日
2026年5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
- H-46388
- R01DA062408 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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。