Major Depressive Disorder, Opioid Use Disorder, Severe, in Early Remission, Opioid Use Disorder, Severe, in Sustained Remission
Conditions
Brief summary
The purpose of the study is to examine whether an investigational medication called ketamine along with psychotherapy is an effective treatment for depression in participants with a history of opioid addiction who have not abused opioids in at least 3 months. Participants will receive ketamine through intramuscular injection along with psychotherapy weekly for 8 weeks. Participation for eligible subjects who decide to enroll (including post-medication follow-up visits) will last about 16 weeks or 4 months.
Interventions
Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
Sponsors
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
A subject may be eligible for enrollment if all the following inclusion criteria apply within the thirty days prior to first experimental session: 1. Between the ages of 18 to 64 years old. 2. Able to provide informed consent. 3. Meet DSM-5 criteria for Major Depressive Disorder, without psychotic features based on clinical interview. 4. Score at least 20 on the Montgomery-Asberg Depression Rating Scale (MADRS, moderate or severe depression). 5. Must meet criteria for opioid use disorder in early or sustained remission criteria by DSM-5 based on clinical interview. 6. Subjects taking other psychotropic medications (e.g. anti-depressants, anxiolytics, methadone, buprenorphine, naltrexone) must be maintained on a stable dose for at least four weeks before study initiation.
Exclusion criteria
Subjects will be excluded from the study if any of the following criteria apply: 1. They are considered an immediate suicide risk by clinician assessment, self-reports a suicide attempt within the past year, or felt to be likely to require hospitalization during the study. 2. Subjects who meet DSM-5 criteria for current bipolar disorder based on clinical interview. 3. Subjects who meet DSM-5 criteria for current or history of psychotic spectrum disorders based on clinical interview. 4. Subjects meeting DSM-5 criteria for current substance use disorder (i.e., not in early or sustained remission) other than tobacco use disorder. 5. Subjects who report use of ketamine \>20 times in the past or who meet DSM-5 criteria for Other Hallucinogen Use Disorder due to ketamine use including subjects who are currently in early or sustained remission. 6. Women who are pregnant or nursing, and women who do not consent to use methods of highly effective birth control during the interventional phase of the study. 7. Subjects with hypertension as defined by a baseline visit systolic blood pressure (SBP) \>140 mmHg or a diastolic blood pressure (DBP) \>90 mmHg. 8. A history of allergic or other adverse reaction to ketamine (or its excipients). 9. Clinically significant physical exam findings or self-reported medical conditions for which a transient increase in blood pressure could be significantly detrimental (e.g. glaucoma, aneurysmal disease, cardiovascular disease, or end-stage renal disease). 10. QTc will be measured in all subjects and those with QTc 450ms or longer will be excluded. 11. Subjects who live greater than 20 miles from the study site and cannot arrange their own transportation will be excluded from the study. 12. Subjects with kidney or liver impairment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery Asberg Depression Rating Scale | Change from baseline measured at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16 | Montgomery Asberg Depression Rating Scale (MADRS). The MADRS is a clinician administered, 10-item questionnaire of depression severity. The total score ranges from 0-60, with scores of 0-6 considered normal (non-depressed), 7-19 indicative of mild depression, 20-34 indicative of moderate depression, and 35-60 indicative of severe depression. Individuals scoring 20 or higher on the MADRS will be included in the study. The MADRS evaluates the following symptoms of depression: 1) clinical appearance of sadness, 2) self-reported sadness, 3) inner tension, 4) reduced sleep, 5) reduced appetite, 6) concentration difficulties, 7) lassitude, 8) inability to feel, 9) pessimistic thought process, and 10) thoughts of suicide. Lower scores are better (less depression). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | Change relative to baseline measured at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16 | Measure of subjective level of opioid craving; maximum score of 100 and minimum score of 0 with higher scores meaning worse outcome (more cravings) |
| Generalized Anxiety Disorder-7 (GAD-7) | Change in score relative to baseline calculated at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16. | Self-report of anxiety symptom severity; minimum score of 0 and maximum score of 21 with higher scores meaning worse outcome (more anxious) |
| Mystical Experience Questionnaire (MEQ) | Measured at week 1-8 | Measure of perceptual experiences; multiple items rated on a 5 point scale with higher scores indicating more intense perceptual experience. Total scores are presented as an average (mean) of the 30 item scale, each of which are rated out of 5. Scale is ordered as follows (in reference to magnitude of various perceptual experiences during acute ketamine session): 0 - none; not at all; 1 - so slight cannot decide; 2 - slight; 3- moderate; 4 - strong (equivalent in degree to any other strong experience); 5- extreme (more than any other time in my life and stronger than 4). |
| Beck Depression Inventory | Change from baseline measured at week 1-9, 10, 12, and 16 | Self-rated depression inventory; minimum score of 0 maximum score of 63 with lower scores being a better outcome (less depressed) |
| PTSD Checklist (PCL-5; PTSD Checklist 5) | Measured at week 1-9, 10, 12, and 16 | Measure of PTSD symptoms; maximum score 80 and minimum score of 0 with higher scores indicating worse outcome (more PTSD symptoms) |
| Timeline Follow-back (TLFB) | Measured at week 1-9, 10, 12, and 16 | Measure of Substance Use; maximum number of substance use days per week is 7 and minimum is 0 with higher number indicating worse outcomes (more substance use) |
| Brief Pain Inventory (BPI) | Measured at baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16 | Measure of pain. Sub-scale 3 specifically was reported for this outcome. Subjects were asked: Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours; maximum score of 10 and minimum of 0 with higher scores indicating worse outcome (more pain) and a score of 0 indicating best outcome (no pain). |
Countries
United States
Participant flow
Recruitment details
Intended total recruitment was 10 participants, however study was concluded after a total of 5 participants were recruited.
Participants by arm
| Arm | Count |
|---|---|
| Ketamine-assisted Psychotherapy Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.
Ketamine-assisted psychotherapy: Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session. | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Acute Intervention (Weeks 1-9 of Study) | Physician Decision | 1 |
| Follow-up Phase (Through Week 16) | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Ketamine-assisted Psychotherapy |
|---|---|
| Age, Continuous | 31.2 years STANDARD_DEVIATION 8.1 |
| BDI Baseline | 42.8 units on a scale STANDARD_DEVIATION 7.7 |
| GAD-7 Baseline | 18.4 units on a scale STANDARD_DEVIATION 1.8 |
| MADRS baseline | 34.0 units on a scale STANDARD_DEVIATION 6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 1 Participants |
| Sexual orientation Bisexual | 1 Participants |
| Sexual orientation Heterosexual | 3 Participants |
| Sexual orientation Homosexual | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 3 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Montgomery Asberg Depression Rating Scale
Montgomery Asberg Depression Rating Scale (MADRS). The MADRS is a clinician administered, 10-item questionnaire of depression severity. The total score ranges from 0-60, with scores of 0-6 considered normal (non-depressed), 7-19 indicative of mild depression, 20-34 indicative of moderate depression, and 35-60 indicative of severe depression. Individuals scoring 20 or higher on the MADRS will be included in the study. The MADRS evaluates the following symptoms of depression: 1) clinical appearance of sadness, 2) self-reported sadness, 3) inner tension, 4) reduced sleep, 5) reduced appetite, 6) concentration difficulties, 7) lassitude, 8) inability to feel, 9) pessimistic thought process, and 10) thoughts of suicide. Lower scores are better (less depression).
Time frame: Change from baseline measured at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16
Population: Includes participants with available data. One participant dropped out after week 2, another failed to follow-up after week 9.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ketamine-assisted Psychotherapy | Montgomery Asberg Depression Rating Scale | Week 1 | -1.75 score on a scale | Standard Deviation 3.5 |
| Ketamine-assisted Psychotherapy | Montgomery Asberg Depression Rating Scale | Week 2 | -3.25 score on a scale | Standard Deviation 3 |
| Ketamine-assisted Psychotherapy | Montgomery Asberg Depression Rating Scale | Week 3 | -7.25 score on a scale | Standard Deviation 7.27 |
| Ketamine-assisted Psychotherapy | Montgomery Asberg Depression Rating Scale | Week 4 | -11.75 score on a scale | Standard Deviation 7.37 |
| Ketamine-assisted Psychotherapy | Montgomery Asberg Depression Rating Scale | Week 5 | -9 score on a scale | Standard Deviation 6.98 |
| Ketamine-assisted Psychotherapy | Montgomery Asberg Depression Rating Scale | Week 6 | -18.3 score on a scale | Standard Deviation 6.18 |
| Ketamine-assisted Psychotherapy | Montgomery Asberg Depression Rating Scale | Week 7 | -19 score on a scale | Standard Deviation 4.83 |
| Ketamine-assisted Psychotherapy | Montgomery Asberg Depression Rating Scale | Week 8 | -20 score on a scale | Standard Deviation 6.32 |
| Ketamine-assisted Psychotherapy | Montgomery Asberg Depression Rating Scale | Week 9 | -15.5 score on a scale | Standard Deviation 7.55 |
| Ketamine-assisted Psychotherapy | Montgomery Asberg Depression Rating Scale | Week 10 | -10.7 score on a scale | Standard Deviation 12.7 |
| Ketamine-assisted Psychotherapy | Montgomery Asberg Depression Rating Scale | Week 12 | -8.33 score on a scale | Standard Deviation 18.15 |
| Ketamine-assisted Psychotherapy | Montgomery Asberg Depression Rating Scale | Week 16 | -10.67 score on a scale | Standard Deviation 15.82 |
Secondary
Beck Depression Inventory
Self-rated depression inventory; minimum score of 0 maximum score of 63 with lower scores being a better outcome (less depressed)
Time frame: Change from baseline measured at week 1-9, 10, 12, and 16
Population: Includes participants with available data. One participant dropped out after week 2, another failed to follow-up after week 9.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ketamine-assisted Psychotherapy | Beck Depression Inventory | Week 1 | -1.6 score on a scale | Standard Deviation 1.7 |
| Ketamine-assisted Psychotherapy | Beck Depression Inventory | Week 2 | -6.4 score on a scale | Standard Deviation 5 |
| Ketamine-assisted Psychotherapy | Beck Depression Inventory | Week 3 | -8.8 score on a scale | Standard Deviation 11.3 |
| Ketamine-assisted Psychotherapy | Beck Depression Inventory | Week 5 | -9 score on a scale | Standard Deviation 12.2 |
| Ketamine-assisted Psychotherapy | Beck Depression Inventory | Week 6 | -13 score on a scale | Standard Deviation 9.1 |
| Ketamine-assisted Psychotherapy | Beck Depression Inventory | Week 7 | -15.5 score on a scale | Standard Deviation 8.5 |
| Ketamine-assisted Psychotherapy | Beck Depression Inventory | Week 8 | -18 score on a scale | Standard Deviation 9.6 |
| Ketamine-assisted Psychotherapy | Beck Depression Inventory | Week 9 | -17.3 score on a scale | Standard Deviation 10.3 |
| Ketamine-assisted Psychotherapy | Beck Depression Inventory | Week 10 | -15.3 score on a scale | Standard Deviation 9.5 |
| Ketamine-assisted Psychotherapy | Beck Depression Inventory | Week 12 | -13.7 score on a scale | Standard Deviation 16.3 |
| Ketamine-assisted Psychotherapy | Beck Depression Inventory | Week 16 | -16.7 score on a scale | Standard Deviation 9.9 |
| Ketamine-assisted Psychotherapy | Beck Depression Inventory | Week 4 | -11.8 score on a scale | Standard Deviation 9.8 |
Secondary
Brief Pain Inventory (BPI)
Measure of pain. Sub-scale 3 specifically was reported for this outcome. Subjects were asked: Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours; maximum score of 10 and minimum of 0 with higher scores indicating worse outcome (more pain) and a score of 0 indicating best outcome (no pain).
Time frame: Measured at baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16
Population: Includes participants with available data. One participant dropped out after week 2, another failed to follow-up after week 9.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ketamine-assisted Psychotherapy | Brief Pain Inventory (BPI) | Baseline | 1.4 score on a scale | Standard Deviation 1.95 |
| Ketamine-assisted Psychotherapy | Brief Pain Inventory (BPI) | Week 1 | 1.6 score on a scale | Standard Deviation 2.3 |
| Ketamine-assisted Psychotherapy | Brief Pain Inventory (BPI) | Week 2 | 1.2 score on a scale | Standard Deviation 2.17 |
| Ketamine-assisted Psychotherapy | Brief Pain Inventory (BPI) | Week 3 | 0.33 score on a scale | Standard Deviation 0.58 |
| Ketamine-assisted Psychotherapy | Brief Pain Inventory (BPI) | Week 4 | 0 score on a scale | Standard Deviation 0 |
| Ketamine-assisted Psychotherapy | Brief Pain Inventory (BPI) | Week 5 | 0 score on a scale | Standard Deviation 0 |
| Ketamine-assisted Psychotherapy | Brief Pain Inventory (BPI) | Week 6 | 0 score on a scale | Standard Deviation 0 |
| Ketamine-assisted Psychotherapy | Brief Pain Inventory (BPI) | Week 7 | 0 score on a scale | Standard Deviation 0 |
| Ketamine-assisted Psychotherapy | Brief Pain Inventory (BPI) | Week 8 | 0 score on a scale | Standard Deviation 0 |
| Ketamine-assisted Psychotherapy | Brief Pain Inventory (BPI) | Week 9 | 0 score on a scale | Standard Deviation 0 |
| Ketamine-assisted Psychotherapy | Brief Pain Inventory (BPI) | Week 10 | 0 score on a scale | Standard Deviation 0 |
| Ketamine-assisted Psychotherapy | Brief Pain Inventory (BPI) | Week 12 | 0 score on a scale | Standard Deviation 0 |
| Ketamine-assisted Psychotherapy | Brief Pain Inventory (BPI) | Week 16 | 0 score on a scale | Standard Deviation 0 |
Secondary
Generalized Anxiety Disorder-7 (GAD-7)
Self-report of anxiety symptom severity; minimum score of 0 and maximum score of 21 with higher scores meaning worse outcome (more anxious)
Time frame: Change in score relative to baseline calculated at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16.
Population: Includes participants with available data. One participant dropped out after week 2, another failed to follow-up after week 9.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ketamine-assisted Psychotherapy | Generalized Anxiety Disorder-7 (GAD-7) | Week 1 | -2.2 score on a scale | Standard Deviation 3.35 |
| Ketamine-assisted Psychotherapy | Generalized Anxiety Disorder-7 (GAD-7) | Week 2 | -4.2 score on a scale | Standard Deviation 3.11 |
| Ketamine-assisted Psychotherapy | Generalized Anxiety Disorder-7 (GAD-7) | Week 3 | -6.75 score on a scale | Standard Deviation 4.72 |
| Ketamine-assisted Psychotherapy | Generalized Anxiety Disorder-7 (GAD-7) | Week 4 | -6.5 score on a scale | Standard Deviation 3.11 |
| Ketamine-assisted Psychotherapy | Generalized Anxiety Disorder-7 (GAD-7) | Week 5 | -6.25 score on a scale | Standard Deviation 3.59 |
| Ketamine-assisted Psychotherapy | Generalized Anxiety Disorder-7 (GAD-7) | Week 6 | -8.75 score on a scale | Standard Deviation 4.43 |
| Ketamine-assisted Psychotherapy | Generalized Anxiety Disorder-7 (GAD-7) | Week 7 | -7 score on a scale | Standard Deviation 5.03 |
| Ketamine-assisted Psychotherapy | Generalized Anxiety Disorder-7 (GAD-7) | Week 8 | -9 score on a scale | Standard Deviation 3.37 |
| Ketamine-assisted Psychotherapy | Generalized Anxiety Disorder-7 (GAD-7) | Week 9 | -8.75 score on a scale | Standard Deviation 4.92 |
| Ketamine-assisted Psychotherapy | Generalized Anxiety Disorder-7 (GAD-7) | Week 10 | -6.33 score on a scale | Standard Deviation 4.16 |
| Ketamine-assisted Psychotherapy | Generalized Anxiety Disorder-7 (GAD-7) | Week 12 | -8.33 score on a scale | Standard Deviation 6.11 |
| Ketamine-assisted Psychotherapy | Generalized Anxiety Disorder-7 (GAD-7) | Week 16 | -9 score on a scale | Standard Deviation 5 |
Secondary
Mystical Experience Questionnaire (MEQ)
Measure of perceptual experiences; multiple items rated on a 5 point scale with higher scores indicating more intense perceptual experience. Total scores are presented as an average (mean) of the 30 item scale, each of which are rated out of 5. Scale is ordered as follows (in reference to magnitude of various perceptual experiences during acute ketamine session): 0 - none; not at all; 1 - so slight cannot decide; 2 - slight; 3- moderate; 4 - strong (equivalent in degree to any other strong experience); 5- extreme (more than any other time in my life and stronger than 4).
Time frame: Measured at week 1-8
Population: Includes participants with available data. One participant dropped out after week 2, another failed to follow-up after week 9.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ketamine-assisted Psychotherapy | Mystical Experience Questionnaire (MEQ) | Week 1 | 2.96 score on a scale | Standard Deviation 1.2 |
| Ketamine-assisted Psychotherapy | Mystical Experience Questionnaire (MEQ) | Week 2 | 2.32 score on a scale | Standard Deviation 1.37 |
| Ketamine-assisted Psychotherapy | Mystical Experience Questionnaire (MEQ) | Week 3 | 3.55 score on a scale | Standard Deviation 0.81 |
| Ketamine-assisted Psychotherapy | Mystical Experience Questionnaire (MEQ) | Week 4 | 3.54 score on a scale | Standard Deviation 0.81 |
| Ketamine-assisted Psychotherapy | Mystical Experience Questionnaire (MEQ) | Week 5 | 3.88 score on a scale | Standard Deviation 0.87 |
| Ketamine-assisted Psychotherapy | Mystical Experience Questionnaire (MEQ) | Week 6 | 3.25 score on a scale | Standard Deviation 0.84 |
| Ketamine-assisted Psychotherapy | Mystical Experience Questionnaire (MEQ) | Week 7 | 4.28 score on a scale | Standard Deviation 0.55 |
| Ketamine-assisted Psychotherapy | Mystical Experience Questionnaire (MEQ) | Week 8 | 3.9 score on a scale | Standard Deviation 0.78 |
Secondary
PTSD Checklist (PCL-5; PTSD Checklist 5)
Measure of PTSD symptoms; maximum score 80 and minimum score of 0 with higher scores indicating worse outcome (more PTSD symptoms)
Time frame: Measured at week 1-9, 10, 12, and 16
Population: Includes participants with available data. Four patient endorses trauma and completed PCL at least once. One participant inconsistently endorsed trauma depending on assessment week, leading to variation in number of participants analyzed each week. One participant dropped out after week 2, another failed to follow-up after week 9.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ketamine-assisted Psychotherapy | PTSD Checklist (PCL-5; PTSD Checklist 5) | Week 1 | 64 score on a scale | Standard Deviation 7.55 |
| Ketamine-assisted Psychotherapy | PTSD Checklist (PCL-5; PTSD Checklist 5) | Week 2 | 54 score on a scale | Standard Deviation 17.08 |
| Ketamine-assisted Psychotherapy | PTSD Checklist (PCL-5; PTSD Checklist 5) | Week 3 | 42.33 score on a scale | Standard Deviation 19.09 |
| Ketamine-assisted Psychotherapy | PTSD Checklist (PCL-5; PTSD Checklist 5) | Week 4 | 45.33 score on a scale | Standard Deviation 18.04 |
| Ketamine-assisted Psychotherapy | PTSD Checklist (PCL-5; PTSD Checklist 5) | Week 5 | 44 score on a scale | Standard Deviation 21.21 |
| Ketamine-assisted Psychotherapy | PTSD Checklist (PCL-5; PTSD Checklist 5) | Week 6 | 32.33 score on a scale | Standard Deviation 18.93 |
| Ketamine-assisted Psychotherapy | PTSD Checklist (PCL-5; PTSD Checklist 5) | Week 7 | 37 score on a scale | Standard Deviation 31.11 |
| Ketamine-assisted Psychotherapy | PTSD Checklist (PCL-5; PTSD Checklist 5) | Week 8 | 36 score on a scale | Standard Deviation 19.8 |
| Ketamine-assisted Psychotherapy | PTSD Checklist (PCL-5; PTSD Checklist 5) | Week 9 | 37 score on a scale | Standard Deviation 25.46 |
| Ketamine-assisted Psychotherapy | PTSD Checklist (PCL-5; PTSD Checklist 5) | Week 10 | 40.5 score on a scale | Standard Deviation 28.99 |
| Ketamine-assisted Psychotherapy | PTSD Checklist (PCL-5; PTSD Checklist 5) | Week 12 | 39 score on a scale | Standard Deviation 33.94 |
| Ketamine-assisted Psychotherapy | PTSD Checklist (PCL-5; PTSD Checklist 5) | Week 16 | 38.5 score on a scale | Standard Deviation 27.58 |
Secondary
Timeline Follow-back (TLFB)
Measure of Substance Use; maximum number of substance use days per week is 7 and minimum is 0 with higher number indicating worse outcomes (more substance use)
Time frame: Measured at week 1-9, 10, 12, and 16
Population: Includes participants with available data. One participant dropped out after week 2, another failed to follow-up after week 9.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ketamine-assisted Psychotherapy | Timeline Follow-back (TLFB) | Week 1 | 0.6 days per week | Standard Deviation 1.34 |
| Ketamine-assisted Psychotherapy | Timeline Follow-back (TLFB) | Week 2 | 0 days per week | Standard Deviation 0 |
| Ketamine-assisted Psychotherapy | Timeline Follow-back (TLFB) | Week 3 | 0 days per week | Standard Deviation 0 |
| Ketamine-assisted Psychotherapy | Timeline Follow-back (TLFB) | Week 4 | 0 days per week | Standard Deviation 0 |
| Ketamine-assisted Psychotherapy | Timeline Follow-back (TLFB) | Week 16 | 0 days per week | Standard Deviation 0 |
| Ketamine-assisted Psychotherapy | Timeline Follow-back (TLFB) | Week 5 | 1 days per week | Standard Deviation 2 |
| Ketamine-assisted Psychotherapy | Timeline Follow-back (TLFB) | Week 6 | 0.35 days per week | Standard Deviation 0.7 |
| Ketamine-assisted Psychotherapy | Timeline Follow-back (TLFB) | Week 7 | 0 days per week | Standard Deviation 0 |
| Ketamine-assisted Psychotherapy | Timeline Follow-back (TLFB) | Week 8 | 0 days per week | Standard Deviation 0 |
| Ketamine-assisted Psychotherapy | Timeline Follow-back (TLFB) | Week 9 | 0 days per week | Standard Deviation 0 |
| Ketamine-assisted Psychotherapy | Timeline Follow-back (TLFB) | Week 10 | 0 days per week | Standard Deviation 0 |
| Ketamine-assisted Psychotherapy | Timeline Follow-back (TLFB) | Week 12 | 0 days per week | Standard Deviation 0 |
Secondary
Visual Analog Scale (VAS)
Measure of subjective level of opioid craving; maximum score of 100 and minimum score of 0 with higher scores meaning worse outcome (more cravings)
Time frame: Change relative to baseline measured at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16
Population: Includes participants with available data. One participant dropped out after week 2, another failed to follow-up after week 9.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ketamine-assisted Psychotherapy | Visual Analog Scale (VAS) | Week 1 | 5 score on a scale | Standard Deviation 17.97 |
| Ketamine-assisted Psychotherapy | Visual Analog Scale (VAS) | Week 2 | 5 score on a scale | Standard Deviation 37.3 |
| Ketamine-assisted Psychotherapy | Visual Analog Scale (VAS) | Week 3 | 9.25 score on a scale | Standard Deviation 43.14 |
| Ketamine-assisted Psychotherapy | Visual Analog Scale (VAS) | Week 4 | 4.75 score on a scale | Standard Deviation 47.77 |
| Ketamine-assisted Psychotherapy | Visual Analog Scale (VAS) | Week 5 | 10 score on a scale | Standard Deviation 49.48 |
| Ketamine-assisted Psychotherapy | Visual Analog Scale (VAS) | Week 6 | -1.25 score on a scale | Standard Deviation 38.43 |
| Ketamine-assisted Psychotherapy | Visual Analog Scale (VAS) | Week 7 | -1.75 score on a scale | Standard Deviation 33.09 |
| Ketamine-assisted Psychotherapy | Visual Analog Scale (VAS) | Week 8 | 1.25 score on a scale | Standard Deviation 36.55 |
| Ketamine-assisted Psychotherapy | Visual Analog Scale (VAS) | Week 9 | -6 score on a scale | Standard Deviation 38.17 |
| Ketamine-assisted Psychotherapy | Visual Analog Scale (VAS) | Week 10 | -2 score on a scale | Standard Deviation 55.03 |
| Ketamine-assisted Psychotherapy | Visual Analog Scale (VAS) | Week 12 | -4.33 score on a scale | Standard Deviation 54.63 |
| Ketamine-assisted Psychotherapy | Visual Analog Scale (VAS) | Week 16 | -11 score on a scale | Standard Deviation 42.58 |