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R01DA057631

Project Grant

Overview

Grant Description
Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement for Tobacco Dependence and Other Drug Use in Methadone Treatment - Project Summary

Polysubstance use is common among people with an opioid use disorder (OUD). Although approximately 80% of people with OUD smoke cigarettes, tobacco use is rarely addressed in OUD treatment. Smoking cessation interventions that are effective in the general population have been minimally effective among people with an OUD. However, smoking cessation is related to reduced drug relapse in this population. Pain and distress, which affect most people receiving methadone treatment (MT) for OUD, are thought to contribute to continued opioid, tobacco, and other drug use. Unfortunately, MT programs and smoking cessation interventions typically fail to address the physical pain, emotion dysregulation, and reward processing deficits that co-occur with substance use. Therefore, novel behavioral interventions are needed to address these factors and to support opioid, tobacco, and other drug abstinence simultaneously in this population, in order to save and improve lives.

Mindfulness-Oriented Recovery Enhancement (MORE) is a novel behavioral intervention that shows promise for addressing opioid, tobacco, and other substance use separately. However, it has never been evaluated to address polysubstance use simultaneously. MORE integrates training in mindfulness, reappraisal, and savoring skills into an 8-week group therapy designed to remediate hedonic dysregulation in brain reward systems underlying substance use disorders.

Additionally, motivation and self-efficacy for tobacco and other drug use abstinence often differ from motivation and self-efficacy for opioid use abstinence among people in MT. Therefore, we will examine the impact of Motivational Interviewing (MI) relative to treatment as usual (i.e., "no MI"), prior to MORE or a support group (SG) control intervention, on treatment engagement and outcomes.

To address opioid, tobacco, and other drug use simultaneously among people in MT who smoke cigarettes, we will conduct a 2 x 2 randomized trial of MORE vs. a SG, with or without MI. All participants will receive combination nicotine replacement therapy (C-NRT). The expedited implementation and dissemination of effective interventions is needed. However, the uptake of novel interventions may be slow in MT due to limited time and resources. To best address potential implementation issues and to optimize future MI and MORE implementation and dissemination, this study will utilize a type 2, hybrid implementation-effectiveness study design. This will allow us to evaluate an implementation strategy and assess barriers and facilitators to integrating MI and MORE for polysubstance use into MT.

The objectives of this study are as follows:
1) Determine MORE's effectiveness for decreasing tobacco, opioid, and other drug use simultaneously among people in MT who smoke (N=420).
2) Determine the effectiveness of an MI session, relative to treatment as usual, for increasing treatment engagement and motivation for decreasing opioid, tobacco, and other drug use.
3) Examine barriers and facilitators to implementing MI and MORE for polysubstance use and evaluate strategies for optimizing training, fidelity, and clinic uptake.
Funding Goals
TO SUPPORT BASIC AND CLINICAL NEUROSCIENCE, BIOMEDICAL, BEHAVIORAL AND SOCIAL SCIENCE, EPIDEMIOLOGIC, HEALTH SERVICES AND HEALTH DISPARITY RESEARCH. TO DEVELOP NEW KNOWLEDGE AND APPROACHES RELATED TO THE PREVENTION, DIAGNOSIS, TREATMENT, ETIOLOGY, AND CONSEQUENCES OF DRUG ABUSE AND ADDICTION, INCLUDING HIV/AIDS. TO SUPPORT RESEARCH TRAINING AND RESEARCH SCIENTIST DEVELOPMENT. TO SUPPORT DISSEMINATION OF RESEARCH FINDINGS. SMALL BUSINESS INNOVATION RESEARCH (SBIR) LEGISLATION IS INTENDED TO EXPAND AND IMPROVE THE SBIR PROGRAMS TO EMPHASIZE AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF TECHNOLOGY DEVELOPED THROUGH FEDERAL SBIR RESEARCH AND DEVELOPMENT, INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN THE SBIR PROGRAM. THE LEGISLATION INTENDS THAT THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.
Place of Performance
Newark, New Jersey 071073001 United States
Geographic Scope
Single Zip Code
Analysis Notes
Amendment Since initial award the End Date has been extended from 09/29/25 to 08/31/27 and the total obligations have increased 32% from $2,300,742 to $3,032,237.
Rutgers The State University Of New Jersey was awarded MORE & MI for Polysubstance Use in MT Project Grant R01DA057631 worth $3,032,237 from National Institute on Drug Abuse in September 2022 with work to be completed primarily in Newark New Jersey United States. The grant has a duration of 5 years and was awarded through assistance program 93.279 Drug Abuse and Addiction Research Programs. The Project Grant was awarded through grant opportunity HEAL Initiative: Understanding Polysubstance Use and Improving Service Delivery to Address Polysubstance Use (R01 Clinical Trial Optional).

Status
(Ongoing)

Last Modified 8/6/25

Period of Performance
9/30/22
Start Date
8/31/27
End Date
61.0% Complete

Funding Split
$3.0M
Federal Obligation
$0.0
Non-Federal Obligation
$3.0M
Total Obligated
100.0% Federal Funding
0.0% Non-Federal Funding

Activity Timeline

Interactive chart of timeline of amendments to R01DA057631

Subgrant Awards

Disclosed subgrants for R01DA057631

Transaction History

Modifications to R01DA057631

Additional Detail

Award ID FAIN
R01DA057631
SAI Number
R01DA057631-500705150
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Public/State Controlled Institution Of Higher Education
Awarding Office
75N600 NIH National Insitute on Drug Abuse
Funding Office
75N600 NIH National Insitute on Drug Abuse
Awardee UEI
YVVTQD8CJC79
Awardee CAGE
6VL59
Performance District
NJ-10
Senators
Robert Menendez
Cory Booker

Budget Funding

Federal Account Budget Subfunction Object Class Total Percentage
National Institute on Drug Abuse, National Institutes of Health, Health and Human Services (075-0893) Health research and training Grants, subsidies, and contributions (41.0) $2,300,742 100%
Modified: 8/6/25