Opioid Use DisorderNCT06008769
Therapy for People With Opioid Use Disorder
A study testing 12 Week Manualized Cognitive-Behavioral Therapy Intervention in people with Opioid Use Disorder, run by Philadelphia College of Osteopathic Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- 12 Week Manualized Cognitive-Behavioral Therapy Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2023to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient at Prevention Point Philadelphia
- 18 years or older
- Living with opioid use disorder
- Has a goal to reduce or eliminate illicit opioid use
- Able to provide informed consent
Who cannot join
- 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")
Trial locations and contacts
1 site in 1 country.
United States1 site
Prevention Point Philadelphia
Philadelphia, Pennsylvania, 19134
About this study
Official title: Cognitive-Behavioral Therapy for Opioid Use Disorder: A Manualized Pilot Study
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.
Read the detailed description
Cognitive-Behavioral Therapy (CBT) is one of the most well-supported and widely used psychosocial treatments for substance use disorders (SUDs); however, few studies have evaluated the efficacy of CBT for opioid use disorder (OUD). This prospective, longitudinal pilot study (pre-post design) will assess the feasibility of the first manualized CBT treatment for OUD in adults (N = 20) in a community-based setting (Prevention Point Philadelphia). This study will utilize clinical (urinalysis), patient-reported, and provider-reported outcomes (mood, support, feasibility, satisfaction with treatment) over 12 weeks of a manualized cognitive-behavioral treatment for OUD. This prospective, longitudinal pilot study will evaluate the feasibility of a novel psychotherapy for OUD. This study will utilize both clinical (urinalysis) and patient or provider-reported (mood, support, feasibility) outcomes to assess the feasibility of 12 weeks of manualized cognitive-behavioral treatment for OUD. All study recruitment, consent and intervention delivery will occur at Prevention Point (2913-15 Kensington Ave, Philadelphia, PA). Outcomes will include participant-reported treatment satisfaction, as well as EMR-extracted clinical data (session attendance, urinalysis, mood, demographics, medical information, and recovery-related support).
We hypothesize that individuals with OUD will demonstrate a reduction illicit opioid use from baseline to week 12 as assessed by urinalysis (% change, positive/negative). As a secondary outcome, use of other substances will also be assessed from baseline to week 12 (e.g., alcohol, cocaine). Use of medication for OUD (MOUD; e.g., buprenorphine. methadone) will be accounted for in analyses.
We hypothesize that mood and perceptions of recovery-related resources will improve from baseline to week 12.
As an exploratory aim, we will evaluate intervention feasibility through electronic medical record (EMR) data of number of sessions attended over 12 weeks, treatment fidelity checklists, and a participant survey of treatment satisfaction.
- Conditions
- Opioid Use Disorder
- Being tested
- 12 Week Manualized Cognitive-Behavioral Therapy Intervention
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 Week Manualized Cognitive-Behavioral Therapy InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 12 Week Manualized Cognitive-Behavioral Therapy Intervention | Experimental | Participants will receive a once-per-week, 12 week manualized cognitive-behavioral therapy intervention. Receives: Behavioral: 12 Week Manualized Cognitive-Behavioral Therapy Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinalysis-confirmed Reduction or Elimination of Illicit Opioid Use
Measured: Baseline, 12 weeks
Secondary outcomes (3)
The Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a nine-item instrument (0-3 Likert type scale) for monitoring and measuring depression severity over the past two weeks. The PHQ-9 has strong validity and reliability and is frequently used in clinical settings. The PHQ-9 is scored on a 4-point Likert-type scale, with the lowest value being "Not at All" and the highest value being "Nearly Every Day" with higher overall scores indicating more severe depression.
Measured: Baseline, 12 weeks
The Brief Assessment of Recovery Capital (BARC-10)
The BARC-10 is a 10-item measure assessing the perceived characteristics and assets and individual develops on their recovery journey. The BARC-10 has high internal consistency (α = .90). The BARC-10 is scored on a 6-point Likert-type scale ranging from "Strongly Disagree" to "Strongly Agree" with higher scores indicating higher recovery capital.
Measured: Baseline, 12 weeks
The Client Satisfaction Questionnaire-8 (CSQ-8)
The CSQ-8 is a brief, eight-item treatment satisfaction questionnaire. The CSQ-8 is scored on a series of 4-point Likert-type scales, with higher scores indicating greater treatment satisfaction.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start6 Aug 2023
- Primary completion17 Jun 2024
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philadelphia College of Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Prevention Point Philadelphia
- Responsible party
- Sponsor
- Investigators
- Michelle R Lent, PhD, Principal investigator, Philadelphia College of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008769
- Sponsor's protocol ID
- H23-025
- Status last verified
- Jun 2024
- First submitted
- 17 Aug 2023
- Last updated
- 25 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26406300Center 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/
PubMed 22514846Guidelines for the Psychosocially Assisted Pharmacological Treatment of Opioid Dependence. Geneva: World Health Organization; 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK143185/
PubMed 23762965Dugosh 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.
PubMed 26808307Seth 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.
PubMed 29596405McHugh 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.
PubMed 20599130Substance Abuse and Mental Health Services Administration. Behavioral health treatments and services; 2017. Retrieved from https://www.samhsa.gov/treatment. Accessed September 6. 2018.
Beck AT. Cognitive therapy: nature and relation to behavior therapy. Behav Ther. 1970;1(2),184-200.
Ellis A. Reason and Emotion in Psychotherapy. New York, NY: Stuart; 1962.
Festinger DS, Lent MR. Cognitive-Behavioral Therapy (CBT) for the Treatment of Opioid Use Disorder. Trafford Publishing; 2022 Aug 18.
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.
PubMed 33971028Moore 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.
PubMed 22614936Fiellin 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.
PubMed 23260506Ling 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.
PubMed 23734858Kroenke 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.
PubMed 11556941
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-Behavioral Therapy for Opioid Use Disorder: A Manualized Pilot Study
- ClinicalTrials.gov ID
- NCT06008769
- Acronym / sponsor ID
- H23-025
- Conditions
- Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Philadelphia College of Osteopathic MedicineUniversity, hospital or other
- Collaborators
- Prevention Point Philadelphia
- Study start
- 6 Aug 2023 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- Aug 2024 (estimated)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cognitive-Behavioral Therapy (CBT) is one of the most well-supported and widely used psychosocial treatments for substance use disorders (SUDs); however, few studies have evaluated the efficacy of CBT for opioid use disorder (OUD). This prospective, longitudinal pilot study (pre-post design) will assess the feasibility of the first manualized CBT treatment for OUD in adults (N = 20) in a community-based setting (Prevention Point Philadelphia). This study will utilize clinical (urinalysis), patient-reported, and provider-reported outcomes (mood, support, feasibility, satisfaction with treatment) over 12 weeks of a manualized cognitive-behavioral treatment for OUD. This prospective, longitudinal pilot study will evaluate the feasibility of a novel psychotherapy for OUD. This study will utilize both clinical (urinalysis) and patient or provider-reported (mood, support, feasibility) outcomes to assess the feasibility of 12 weeks of manualized cognitive-behavioral treatment for OUD. All study recruitment, consent and intervention delivery will occur at Prevention Point (2913-15 Kensington Ave, Philadelphia, PA). Outcomes will include participant-reported treatment satisfaction, as well as EMR-extracted clinical data (session attendance, urinalysis, mood, demographics, medical information, and recovery-related support).
We hypothesize that individuals with OUD will demonstrate a reduction illicit opioid use from baseline to week 12 as assessed by urinalysis (% change, positive/negative). As a secondary outcome, use of other substances will also be assessed from baseline to week 12 (e.g., alcohol, cocaine). Use of medication for OUD (MOUD; e.g., buprenorphine. methadone) will be accounted for in analyses.
We hypothesize that mood and perceptions of recovery-related resources will improve from baseline to week 12.
As an exploratory aim, we will evaluate intervention feasibility through electronic medical record (EMR) data of number of sessions attended over 12 weeks, treatment fidelity checklists, and a participant survey of treatment satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 12 Week Manualized Cognitive-Behavioral Therapy Intervention | Experimental | Behavioral: 12 Week Manualized Cognitive-Behavioral Therapy InterventionParticipants will receive a once-per-week, 12 week manualized cognitive-behavioral therapy intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient at Prevention Point Philadelphia
- 18 years or older
- Living with opioid use disorder
- Has a goal to reduce or eliminate illicit opioid use
- Able to provide informed consent
Key exclusion criteria (2 listed)
- 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")
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12 Week Manualized Cognitive-Behavioral Therapy InterventionThe 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. | Behavioural | 12 Week Manualized Cognitive-Behavioral Therapy Intervention |
Primary outcome
Urinalysis-confirmed Reduction or Elimination of Illicit Opioid Use
Time frame: Baseline, 12 weeks
3 secondary outcomes
The Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, 12 weeks
The Brief Assessment of Recovery Capital (BARC-10)
Time frame: Baseline, 12 weeks
The Client Satisfaction Questionnaire-8 (CSQ-8)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Background: PubMed 26406300Kampman 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.
- Background: PubMed 22514846Center 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/
- Background: PubMed 23762965Guidelines for the Psychosocially Assisted Pharmacological Treatment of Opioid Dependence. Geneva: World Health Organization; 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK143185/
- Background: PubMed 26808307Dugosh 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.
- Background: PubMed 29596405Seth 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.
- Background: PubMed 20599130McHugh 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.
- BackgroundSubstance Abuse and Mental Health Services Administration. Behavioral health treatments and services; 2017. Retrieved from https://www.samhsa.gov/treatment. Accessed September 6. 2018.
- BackgroundBeck AT. Cognitive therapy: nature and relation to behavior therapy. Behav Ther. 1970;1(2),184-200.
- BackgroundEllis A. Reason and Emotion in Psychotherapy. New York, NY: Stuart; 1962.
- BackgroundFestinger DS, Lent MR. Cognitive-Behavioral Therapy (CBT) for the Treatment of Opioid Use Disorder. Trafford Publishing; 2022 Aug 18.
- Background: PubMed 33971028Lent 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.
- Background: PubMed 22614936Moore 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle R Lent, PhD principal investigator
Philadelphia College of Osteopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12 Week Manualized Cognitive-Behavioral Therapy Intervention in people with Opioid Use Disorder, run by Philadelphia College of Osteopathic Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinalysis-confirmed Reduction or Elimination of Illicit Opioid Use (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06008769, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.