Not provided
Not provided
Not provided
Not provided
Not provided
Study funds were exhausted
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Methadone is a first-line, evidence-based treatment for opioid use disorder (OUD). Unfortunately, retention and adherence in methadone treatment is a major challenge. OUD patients frequently present with co-morbid depression (OUDCD), a risk factor for poor OUD treatment outcomes, overdose, and suicide. The last two decades have seen an exciting and transformational development in the treatment of depression - ketamine. As a safe, rapid-acting anti-depressant deliverable within the context of methadone maintenance treatment, ketamine could feasibly change the landscape of treatment for OUD patients with comorbid depression. This proposal seeks to evaluate implementation outcomes (feasibility and patient acceptance) as well as preliminary efficacy of ketamine on methadone treatment outcomes for OUD patients (n=6) with comorbid depression and depressive symptoms presenting for methadone treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine Hydrochloride | Drug | Ketamine will be administered by a nurse in a 2-week treatment phase, during which participants will receive six IV infusions of 0.5 mg/kg (over 40-50 minutes) ketamine three times per week. Infusion days for patients will be on Mondays, Wednesdays, and Fridays, +/- 1 day. Ketamine infusions will take place at the UMB General Clinical Research Center (GCRC). The GCRC nurse will deliver ketamine within a private exam room. The infusions will last 40-50 min, and the participant will be observed by the GCRC clinical staff for 2 hours post-infusion. Vital signs will be monitored throughout the treatment; specifically, blood pressure, pulse ox and heart rate will be checked prior to treatment, q20 minutes during infusion, and q30-60 minutes after infusion for up to three hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Study Recruitment | Feasibility will be assessed via participant recruitment: 50% of eligible patients approached will consent to participation in the pilot. | One year |
| Feasibility: Study Retention | 75% of participants will be retained throughout the duration of ketamine infusion procedures | One year |
| Patient Acceptability: Acceptability of the Intervention Measure (AIM) | Acceptance will be assessed via scores on the Acceptability of the Intervention Measure (AIM): Distribution summarized with mean and 95% C.I. Scale values range from 1 to 5 with higher mean values representing greater agreement and/or acceptability. | One month |
| Patient Acceptability: Engagement | Engagement will be assessed via dosing records of observed ketamine administration: distribution of percentage of completed infusions per patient. | One month |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Treatment Retention | One-month (30-day) methadone treatment retention as a binomial (yes/no) variable outcome. | Three months |
| Changes in Psychiatric Diagnosis of Depression | Assessment of changes in depression (MADRS score) will be made at baseline and on the final study day based on a Minimal Clinically Important Difference (MCID) defined change of 1.9 points |
| Measure | Description | Time Frame |
|---|---|---|
| Self-report of illicit substance use | Assessment of changes in number of days of substance use from baseline to the last study contact. Drug use is assessed via self-report of past-two-week use of four common substances: opioids (including heroin, fentanyl, and nonprescribed opioids), cocaine, benzodiazepines, and alcohol; "other" is a fifth category. Total days used (out of a possible 14) is recorded. | One month |
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Annabelle Belcher, PhD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Baltimore | Baltimore | Maryland | 21223 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40844815 | Derived | Manza P, Belcher AM, Fitzsimons H, Spaderna M, Greenblatt AD, Smith HC, Derenoncourt M, Gann D, Farooq U, Kvarta MD, DiPaula BA, Merritt S, Mitic I, Zarate CA, Gould TD, Weintraub E, Kattakuzhy SM. Ketamine to enhance methadone treatment retention in patients with opioid use disorder and co-morbid depression. Am J Drug Alcohol Abuse. 2025;51(5):649-657. doi: 10.1080/00952990.2025.2541212. Epub 2025 Aug 22. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| One month |
| Changes in Depressive Symptoms | Assessment of changes in symptoms of depression, measured with the Patient Health Questionnaire (PHQ-9) will be made at baseline and on the final study day. | One month |
| Subjective Opioid Withdrawal Scale (SOWS) | Assessment of changes in scores on the SOWS from baseline to the last study contact day. SOWS is a 16-item patient self-report instrument to assess common subjective symptoms of craving and withdrawal. | One monrh |
| Objective Opioid Withdrawal Scale (OOWS) | Assessment of changes in scores on the OOWS from baseline to the last study contact day. The OOWS is a 13-item clinical assessment of observable physiological signs of withdrawal. | One month |
| Craving Assessment | Assessment of changes in scores on the Craving Assessment from baseline to the last study contact day. This assessment is an adapted one-item visual-analog scale of self-report of craving for drugs. | One month |
| Pittsburgh Sleep Quality Index (PSQI) | Assessment of changes in scores on the PSQI from baseline to the last study contact day. The PSQI is a self-rated 19-item questionnaire that assesses sleep quality and disturbances over a one-month time interval. Seven component scores are generated: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for the 7 components yields one global score. Assessment of changes will be based on the global score. | One month |
| The Short Inventory of Problems-Revised (SIP-R) | Assessment of changes in scores on the SIP-R from baseline to the last study contact day. The SIP-R is a 15-item self-report assessment of the adverse consequences of substance use. | One month |
| Generalized Anxiety Disorder 7-item scale (GAD-7) | Assessment of changes in scores on the GAD-7 from baseline to the last study contact day. The GAD-7 is a 7-item screen designed to identify individuals with probable anxiety. Each item is scored with a score between 0 and 3 (Not at all sure= 0; Several days= 1; Over half the days= 2; Nearly every day= 3), yielding a total between 0 and 21. | One month |
| Acceptability of the Intervention (AIM) | Assessment of changes in scores on the AIM from baseline to the last study contact day. An established implementation instrument used widely in clinical research, the AIM is a 4-item Likert-type measure of acceptability of an intervention. | One month |
| Clinician Administered Dissociative Symptom Scale (CADSS-6) | Assessment of changes in scores on the CADSS-6 across ketamine infusion days. The CADSS-6 is a 6-item clinician-administered assessment of treatment-emergent dissociation, an adverse event associated with I.V. ketamine; administered 5-10 minutes following cessation of the ketamine infusion on all infusion days | Two weeks |
| Drug Effects Questionnaire-5 (DEQ-5) | Assessment of changes in scores on the CADSS-6 across ketamine infusion days. The DEQ is a five-point self-report visual analogue scale-based assessment of two key aspects of an individual's acute, subjective response to the experience of drug consumption: (i) the strength of substance effects and (ii) desirability of substance effects; administered immediately following CADSS-6 administration. | Two weeks |
| Modified Aldrete | This assessment determines safe discharge from the hospital following each day of ketamine infusion, and will be administered just prior to release. This 5-point clinical assessment is used as a post-operative tool to determine safe discharge following anesthesia. Scores of 0 to 2 are assigned to each of five domains, which include Activity, Respiration, Circulation, Consciousness and Oxygen Saturation. | Two weeks |
| D019964 | Mood Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |