Therapy for People With Opioid Use Disorder

NCT06008769 | Active Not Recruiting

• 1 other identifier: H23-025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot clinical trial is to test the feasibility of a 12-week manualized cognitive-behavioral therapy treatment for opioid use disorder in reducing or stopping illicit opioid use in a community setting. Participants will complete 12 weeks of therapy with a behavioral health counselor and will complete assessments at baseline and 12 weeks. Other outcomes include changes in mood and perceptions of recovery-related support after 12 weeks of therapy.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (1)

• Urinalysis-confirmed Reduction or Elimination of Illicit Opioid Use

  Baseline, 12 weeks

Secondary Outcomes (3)

• The Patient Health Questionnaire-9 (PHQ-9)

  Baseline, 12 weeks

• The Brief Assessment of Recovery Capital (BARC-10)

  Baseline, 12 weeks

• The Client Satisfaction Questionnaire-8 (CSQ-8)

  12 weeks

Study Arms (1)

12 Week Manualized Cognitive-Behavioral Therapy Intervention

EXPERIMENTAL

Participants will receive a once-per-week, 12 week manualized cognitive-behavioral therapy intervention.

Behavioral: 12 Week Manualized Cognitive-Behavioral Therapy Intervention

Interventions

12 Week Manualized Cognitive-Behavioral Therapy Intervention BEHAVIORAL

The manualized intervention, Cognitive Behavioral Therapy for Opioid Use Disorder, was co-written and developed by the study PI, Dr. Lent (see Appendix). The manual consists of one module (Module 0) on assessment and 12 modules of CBT. This study will focus on delivery of Modules 1-12 that focus on several tenets of CBT, including skill development (cognitive restructuring, refusal skills, problem-solving, coping strategies), functional analysis (triggers, reinforcement) and utilizing the cognitive model.

12 Week Manualized Cognitive-Behavioral Therapy Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient at Prevention Point Philadelphia
• years or older
• Living with opioid use disorder
• Has a goal to reduce or eliminate illicit opioid use
• Able to provide informed consent

You may not qualify if:

• Not comfortable receiving psychotherapy in English
• Under custodial supervision through the legal justice system (e.g., halfway house following incarceration, involuntary detention or confinement, status as a "prisoner")

Sponsors & Collaborators

• Philadelphia College of Osteopathic Medicine: lead
• Prevention Point Philadelphia: collaborator

Study Sites (1)

Prevention Point Philadelphia

Philadelphia, Pennsylvania, 19134, United States

Location

Related Publications (17)

• Kampman K, Jarvis M. American Society of Addiction Medicine (ASAM) National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use. J Addict Med. 2015 Sep-Oct;9(5):358-67. doi: 10.1097/ADM.0000000000000166.

  PMID: 26406300 BACKGROUND

• Center for Substance Abuse Treatment. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 2004. Report No.: (SMA) 04-3939. Available from http://www.ncbi.nlm.nih.gov/books/NBK64245/

  PMID: 22514846 BACKGROUND

• Guidelines for the Psychosocially Assisted Pharmacological Treatment of Opioid Dependence. Geneva: World Health Organization; 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK143185/

  PMID: 23762965 BACKGROUND

• Dugosh K, Abraham A, Seymour B, McLoyd K, Chalk M, Festinger D. A Systematic Review on the Use of Psychosocial Interventions in Conjunction With Medications for the Treatment of Opioid Addiction. J Addict Med. 2016 Mar-Apr;10(2):93-103. doi: 10.1097/ADM.0000000000000193.

  PMID: 26808307 BACKGROUND

• Seth P, Scholl L, Rudd RA, Bacon S. Overdose Deaths Involving Opioids, Cocaine, and Psychostimulants - United States, 2015-2016. MMWR Morb Mortal Wkly Rep. 2018 Mar 30;67(12):349-358. doi: 10.15585/mmwr.mm6712a1.

  PMID: 29596405 BACKGROUND

• McHugh RK, Hearon BA, Otto MW. Cognitive behavioral therapy for substance use disorders. Psychiatr Clin North Am. 2010 Sep;33(3):511-25. doi: 10.1016/j.psc.2010.04.012.

  PMID: 20599130 BACKGROUND

• Substance Abuse and Mental Health Services Administration. Behavioral health treatments and services; 2017. Retrieved from https://www.samhsa.gov/treatment. Accessed September 6. 2018.

  BACKGROUND

• Beck AT. Cognitive therapy: nature and relation to behavior therapy. Behav Ther. 1970;1(2),184-200.

  BACKGROUND

• Ellis A. Reason and Emotion in Psychotherapy. New York, NY: Stuart; 1962.

  BACKGROUND

• Festinger DS, Lent MR. Cognitive-Behavioral Therapy (CBT) for the Treatment of Opioid Use Disorder. Trafford Publishing; 2022 Aug 18.

  BACKGROUND

• Lent MR, Callahan HR, Womer P, Mullen PM, Shook CB, DiTomasso RA, Felgoise SH, Festinger DS. A mental health professional survey of cognitive-behavioral therapy for the treatment of opioid use disorder. J Clin Psychol. 2021 Jul;77(7):1607-1613. doi: 10.1002/jclp.23170. Epub 2021 May 10.

  PMID: 33971028 BACKGROUND

• Moore BA, Barry DT, Sullivan LE, O'connor PG, Cutter CJ, Schottenfeld RS, Fiellin DA. Counseling and directly observed medication for primary care buprenorphine maintenance: a pilot study. J Addict Med. 2012 Sep;6(3):205-11. doi: 10.1097/ADM.0b013e3182596492.

  PMID: 22614936 BACKGROUND

• Fiellin DA, Barry DT, Sullivan LE, Cutter CJ, Moore BA, O'Connor PG, Schottenfeld RS. A randomized trial of cognitive behavioral therapy in primary care-based buprenorphine. Am J Med. 2013 Jan;126(1):74.e11-7. doi: 10.1016/j.amjmed.2012.07.005.

  PMID: 23260506 BACKGROUND

• Ling W, Hillhouse M, Ang A, Jenkins J, Fahey J. Comparison of behavioral treatment conditions in buprenorphine maintenance. Addiction. 2013 Oct;108(10):1788-98. doi: 10.1111/add.12266. Epub 2013 Jul 12.

  PMID: 23734858 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Gilbody S, Richards D, Brealey S, Hewitt C. Screening for depression in medical settings with the Patient Health Questionnaire (PHQ): a diagnostic meta-analysis. J Gen Intern Med. 2007 Nov;22(11):1596-602. doi: 10.1007/s11606-007-0333-y. Epub 2007 Sep 14.

  PMID: 17874169 BACKGROUND

• Vilsaint CL, Kelly JF, Bergman BG, Groshkova T, Best D, White W. Development and validation of a Brief Assessment of Recovery Capital (BARC-10) for alcohol and drug use disorder. Drug Alcohol Depend. 2017 Aug 1;177:71-76. doi: 10.1016/j.drugalcdep.2017.03.022. Epub 2017 May 19.

  PMID: 28578224 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Michelle R Lent, PhD

  Philadelphia College of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 24, 2023
• Study Start: August 6, 2023
• Primary Completion: June 17, 2024
• Study Completion: August 1, 2024
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)