Substance Use Disorders Clinical Trial
Official title:
An Innovative Digital Smoking Cessation Intervention for Low-Income Adults With Substance Use Disorder
Verified date | June 2020 |
Source | BrightView LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Adults with substance use disorder (SUD) tend to have started smoking at a younger age and
are more likely to be heavy smokers. Due to the many conflicting priorities in this
population, smoking cessation is often relegated and ignored by both patients and their
healthcare providers. As of 2008, only 2 out of 5 addiction treatment providers in the US
offered behavioral treatment for smoking cessation, and less than 1 in 5 offered
pharmacotherapy. However, many researchers have found that smoking cessation has positive
effects on abstinence from other drugs, as smoking appears to increase craving for and the
likelihood of using drugs.
Contingency Management is a highly-effective, evidence based methodology demonstrated to be
effective at reducing the use of all types of substances in over 100 randomized controlled
trials and 7 meta-analyses. BrightView, an outpatient substance abuse treatment center with
several locations across the state of Ohio, has partnered with DynamiCare Health to implement
DynamiCare's innovative digital Contingency Management (CM) platform among BrightView's
outpatient population of primarily low-income substance use disorder patients with comorbid
nicotine dependence/tobacco use disorder.
DynamiCare's platform automates Contingency Management to support smoking cessation
interventions via smartphone app. This app rewards participants for negative substance tests
and appointment attendance (using GPS tracking) to incentivize abstinence and promote
engagement in treatment.
The goal of this study is to reduce tobacco disparities for low-income adult participants
using DynamiCare's digital intervention, and to build a rapidly scalable, sustainable process
that makes the field of smoking cessation more effective, accountable, and accessible.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | January 15, 2021 |
Est. primary completion date | October 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Must be enrolled in a BrightView outpatient substance use disorder program - Must be active smokers, at least moderate in severity - Must have substance use disorder as their primary diagnosis - Must speak and read English adequately to understand smartphone commands and responses - Must have and use an Android or iOS smartphone with acceptable capability - Must be willing to participate in breath testing and use of the smartphone Exclusion Criteria: - Non-smokers - Those without a smartphone or access to a smartphone |
Country | Name | City | State |
---|---|---|---|
United States | BrightView Colerain Addiction Treatment Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
BrightView LLC | DynamiCare Health, Interact for Health |
United States,
Babb S, Malarcher A, Schauer G, Asman K, Jamal A. Quitting Smoking Among Adults - United States, 2000-2015. MMWR Morb Mortal Wkly Rep. 2017 Jan 6;65(52):1457-1464. doi: 10.15585/mmwr.mm6552a1. — View Citation
Baca CT, Yahne CE. Smoking cessation during substance abuse treatment: what you need to know. J Subst Abuse Treat. 2009 Mar;36(2):205-19. doi: 10.1016/j.jsat.2008.06.003. Epub 2008 Aug 20. Review. — View Citation
Bien TH, Burge R. Smoking and drinking: a review of the literature. Int J Addict. 1990 Dec;25(12):1429-54. Review. — View Citation
Burling TA, Ramsey TG, Seidner AL, Kondo CS. Issues related to smoking cessation among substance abusers. J Subst Abuse. 1997;9:27-40. Review. — View Citation
CDC. Current Cigarette Smoking Among Adults in the United States [Internet]. Centers for Disease Control and Prevention. 2019 [cited 2019 Oct 19]. Available from: https://www.cdc.gov/tobacco/data_statistics/fact_sheets/adult_data/cig_smoking/index.htm
Chait LD, Griffiths RR. Effects of methadone on human cigarette smoking and subjective ratings. J Pharmacol Exp Ther. 1984 Jun;229(3):636-40. — View Citation
Clarke JG, Stein MD, McGarry KA, Gogineni A. Interest in smoking cessation among injection drug users. Am J Addict. 2001 Spring;10(2):159-66. — View Citation
de Castro-Neto AG, Rameh-de-Albuquerque RC, de Medeiros PFP, Uchôa R, Santos BS. Neuroscience of Tobacco and Crack Cocaine Use: Metabolism, Effects, and Symptomatology. In: Neuroscience of Nicotine. Elsevier; 2019. p. 403-410.
DiGiulio A, Jump Z, Yu A, Babb S, Schecter A, Williams KS, Yembra D, Armour BS. State Medicaid Coverage for Tobacco Cessation Treatments and Barriers to Accessing Treatments - United States, 2015-2017. MMWR Morb Mortal Wkly Rep. 2018 Apr 6;67(13):390-395. doi: 10.15585/mmwr.mm6713a3. — View Citation
Epstein DH, Marrone GF, Heishman SJ, Schmittner J, Preston KL. Tobacco, cocaine, and heroin: Craving and use during daily life. Addict Behav. 2010 Apr;35(4):318-24. doi: 10.1016/j.addbeh.2009.11.003. Epub 2009 Nov 12. — View Citation
Fiore MC, Smith SS, Jorenby DE, Baker TB. The effectiveness of the nicotine patch for smoking cessation. A meta-analysis. JAMA. 1994 Jun 22-29;271(24):1940-7. — View Citation
Friedmann PD, Jiang L, Richter KP. Cigarette smoking cessation services in outpatient substance abuse treatment programs in the United States. J Subst Abuse Treat. 2008 Mar;34(2):165-72. Epub 2007 May 23. — View Citation
Friend KB, Pagano ME. Smoking cessation and alcohol consumption in individuals in treatment for alcohol use disorders. J Addict Dis. 2005;24(2):61-75. — View Citation
Frishman WH. Smoking cessation pharmacotherapy--nicotine and non-nicotine preparations. Prev Cardiol. 2007 Spring;10(2 Suppl 1):10-22. Review. — View Citation
Gilpin E, Pierce J, Goodman J, Giovino G, Berry C, Burns D. Trends in physicians' giving advice to stop smoking, United States, 1974-87. Tob Control. 1992;1(1):31-36.
Guydish J, Passalacqua E, Tajima B, Chan M, Chun J, Bostrom A. Smoking prevalence in addiction treatment: a review. Nicotine Tob Res. 2011 Jun;13(6):401-11. doi: 10.1093/ntr/ntr048. Epub 2011 Apr 4. Review. — View Citation
Hughes JR, Kalman D. Do smokers with alcohol problems have more difficulty quitting? Drug Alcohol Depend. 2006 Apr 28;82(2):91-102. Epub 2005 Sep 26. Review. — View Citation
Hurt RD, Offord KP, Croghan IT, Gomez-Dahl L, Kottke TE, Morse RM, Melton LJ 3rd. Mortality following inpatient addictions treatment. Role of tobacco use in a community-based cohort. JAMA. 1996 Apr 10;275(14):1097-103. Erratum in: JAMA 1996 Sep 11;276(10):784. — View Citation
Interact for Health. Tobacco use in Greater Cincinnati. Cincinnati, OH; 2019.
Kalman D, Morissette SB, George TP. Co-morbidity of smoking in patients with psychiatric and substance use disorders. Am J Addict. 2005 Mar-Apr;14(2):106-23. Review. — View Citation
Mello NK, Mendelson JH, Sellers ML, Kuehnle JC. Effects of heroin self-administration on cigarette smoking. Psychopharmacology (Berl). 1980 Jan;67(1):45-52. — View Citation
National Institute on Drug Abuse (NIDA). Cigarette Smoking Increases the Likelihood of Drug Use Relapse [Internet]. 2018 [cited 2019 Oct 19]. Available from: https://www.drugabuse.gov/news-events/nida-notes/2018/05/cigarette-smoking-increases-likelihood-drug-use-relapse
National Institute On Drug Abuse. Tobacco, Nicotine, and E-Cigarettes [Internet]. https://www.drugabuse.gov/publications/research-reports/tobacco-nicotine-e-cigarettes. 2019 [cited 2019 Oct 19]. Available from: https://www.drugabuse.gov/publications/research-reports/tobacco-nicotine-e-cigarettes/introduction
Olsen Y, Alford DP, Horton NJ, Saitz R. Addressing smoking cessation in methadone programs. J Addict Dis. 2005;24(2):33-48. — View Citation
Panel TU and DG. Treating Tobacco Use and Dependence: 2008 Update. US Department of Health and Human Services; 2008.
Prendergast M, Podus D, Finney J, Greenwell L, Roll J. Contingency management for treatment of substance use disorders: a meta-analysis. Addiction. 2006 Nov;101(11):1546-60. Review. — View Citation
Prochaska JJ, Delucchi K, Hall SM. A meta-analysis of smoking cessation interventions with individuals in substance abuse treatment or recovery. J Consult Clin Psychol. 2004 Dec;72(6):1144-56. — View Citation
Richter KP, Ahluwalia HK, Mosier MC, Nazir N, Ahluwalia JS. A population-based study of cigarette smoking among illicit drug users in the United States. Addiction. 2002 Jul;97(7):861-9. — View Citation
Richter KP, McCool RM, Catley D, Hall M, Ahluwalia JS. Dual pharmacotherapy and motivational interviewing for tobacco dependence among drug treatment patients. J Addict Dis. 2005;24(4):79-90. — View Citation
Russell MA, Wilson C, Taylor C, Baker CD. Effect of general practitioners' advice against smoking. Br Med J. 1979 Jul 28;2(6184):231-5. — View Citation
Schroeder SA. What to do with a patient who smokes. JAMA. 2005 Jul 27;294(4):482-7. — View Citation
Spiga R, Schmitz J, Day J 2nd. Effects of nicotine on methadone self-administration in humans. Drug Alcohol Depend. 1998 Apr 1;50(2):157-65. — View Citation
Stevens AB, Dorn SB. The State of Tobacco Use Prevention and Cessation in Ohio - Environmental scan and policy implication [Internet]. Ohio: Health Policy Institute of Ohio; 2015 Jun [cited 2019 Oct 19]. (Health Policy Brief). Available from: https://www.philanthropyohio.org/sites/default/files/PolicyBrief_Tobacco.pdf
Weinberger AH, Platt J, Esan H, Galea S, Erlich D, Goodwin RD. Cigarette Smoking Is Associated With Increased Risk of Substance Use Disorder Relapse: A Nationally Representative, Prospective Longitudinal Investigation. J Clin Psychiatry. 2017 Feb;78(2):e152-e160. doi: 10.4088/JCP.15m10062. — View Citation
West R. The clinical significance of "small" effects of smoking cessation treatments. Addiction. 2007 Apr;102(4):506-9. — View Citation
* Note: There are 35 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Smoking Abstinence | A comparison of the participant's baseline levels of carbon monoxide to post-intervention levels of carbon monoxide. | 4 months | |
Primary | Self-Reported Smoker Status | A comparison of the participant's self-reported smoking severity/status pre- and post-intervention. | 4 months | |
Primary | Attendance Rates | A comparison of the participant's outpatient treatment attendance rates pre- and post-intervention. | 4 months | |
Secondary | Substance Abstinence | A comparison of baseline urine substance test results to post-intervention urine substance test results to measure the impact of smoking cessation on other substance use. | 4 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05660434 -
Using Aromatherapy in Substance Use Disorder
|
N/A | |
Active, not recruiting |
NCT05338268 -
Substance Use and Loneliness
|
N/A | |
Completed |
NCT04098614 -
Barriers to Substance Use Disorder Recovery
|
N/A | |
Completed |
NCT03954184 -
E-health Implementation (Iowa)
|
N/A | |
Completed |
NCT03590106 -
Cardiac Surgery Peer Recovery Support Program
|
N/A | |
Recruiting |
NCT05118204 -
Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization
|
Phase 4 | |
Recruiting |
NCT06273228 -
Parenting Young Children in Pediatrics
|
N/A | |
Recruiting |
NCT05327504 -
Written Exposure Therapy for Veterans With SUD and PTSD
|
N/A | |
Terminated |
NCT03517111 -
The Impact of a Parenting Intervention on Latino Youth Health Behaviors
|
N/A | |
Completed |
NCT04284813 -
Families With Substance Use and Psychosis: A Pilot Study
|
N/A | |
Completed |
NCT04401215 -
Technologically-Augmented Referrals to Mitigate Addiction Consequences
|
N/A | |
Not yet recruiting |
NCT06163651 -
Evaluating a One-Year Version of the Parent-Child Assistance Program
|
N/A | |
Not yet recruiting |
NCT06187701 -
Co-Active Therapeutic Theatre (Co-ATT) for Dual-Diagnosis Patients
|
N/A | |
Recruiting |
NCT04296604 -
Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations
|
N/A | |
Active, not recruiting |
NCT02382042 -
Intensive Referral Intervention to Improve Substance Use Disorder Treatment Outcomes Among Rural and Highly Rural Veterans
|
N/A | |
Terminated |
NCT01356667 -
Drum-Assisted Therapy for Native Americans
|
N/A | |
Completed |
NCT01237366 -
Study Targeting Affect Regulation
|
Phase 1/Phase 2 | |
Completed |
NCT00708890 -
Twelve Step Based Self-help Groups for Substance Related Disorders
|
N/A | |
Active, not recruiting |
NCT04048850 -
Zepatier in Patients With Substance Use
|
||
Recruiting |
NCT05976646 -
Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion
|
Phase 1/Phase 2 |