Trial Outcomes & Findings for The Effects of Minocycline in Opioid-maintained Patients (NCT NCT02359006)
NCT ID: NCT02359006
Last Updated: 2020-03-06
Results Overview
The Cold Pressor Test (CPT) measures pain threshold (in seconds). For this test, two water coolers filled with either warm (100.04ºF/37.8ºC) or cold water (32.9-34.7ºF/0.5-1.5ºC) are used. To begin the CPT, participants first immerse their hand into the warm-water bath for 2 min. Participants are then instructed to immerse their hand into the cold water bath and report the first time they experience pain (pain threshold). Lower scores indicate lower pain threshold. Minimum score is 0 seconds, and a maximum cut-off score of 300 seconds is used to prevent tissue damage.
COMPLETED
NA
27 participants
One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)
2020-03-06
Participant Flow
Fifty-five subjects were screened. Of those, 27 were deemed eligible and enrolled.
Participant milestones
| Measure |
Minocycline
200mg minocycline
Minocycline: Minocycline will be compared with placebo
|
Placebo
Sugar pill
Placebo: Placebo will be compared with minocycline
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of Minocycline in Opioid-maintained Patients
Baseline characteristics by cohort
| Measure |
Minocycline
n=10 Participants
200mg minocycline
Minocycline: Minocycline will be compared with placebo
|
Placebo
n=10 Participants
Sugar pill
Placebo: Placebo will be compared with minocycline
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.5 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
47.9 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
47.2 years
STANDARD_DEVIATION 7.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)The Cold Pressor Test (CPT) measures pain threshold (in seconds). For this test, two water coolers filled with either warm (100.04ºF/37.8ºC) or cold water (32.9-34.7ºF/0.5-1.5ºC) are used. To begin the CPT, participants first immerse their hand into the warm-water bath for 2 min. Participants are then instructed to immerse their hand into the cold water bath and report the first time they experience pain (pain threshold). Lower scores indicate lower pain threshold. Minimum score is 0 seconds, and a maximum cut-off score of 300 seconds is used to prevent tissue damage.
Outcome measures
| Measure |
Minocycline
n=10 Participants
This group received 200mg minocycline 1x/day for 15 days.
|
Placebo
n=10 Participants
This group received a placebo capsule 1x/day for 15 days.
|
|---|---|---|
|
Pain Threshold
Baseline
|
18.72 seconds
Standard Deviation 11.25
|
24.78 seconds
Standard Deviation 13.77
|
|
Pain Threshold
Day 8 (Test Day 1)
|
16.16 seconds
Standard Deviation 6.46
|
24.37 seconds
Standard Deviation 17.57
|
|
Pain Threshold
Day 15 (Test Day 2)
|
16.13 seconds
Standard Deviation 5.67
|
18.46 seconds
Standard Deviation 6.86
|
|
Pain Threshold
Day 22 (Test Day 3)
|
16.21 seconds
Standard Deviation 5.86
|
25.75 seconds
Standard Deviation 15.45
|
|
Pain Threshold
~Day 28 (Follow-up)
|
17.59 seconds
Standard Deviation 9.34
|
21.92 seconds
Standard Deviation 7.93
|
PRIMARY outcome
Timeframe: One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)The Cold Pressor Test (CPT) measures pain threshold and pain tolerance (in seconds). For this test, two water coolers filled with either warm (100.04ºF/37.8ºC) or cold water (32.9-34.7ºF/0.5-1.5ºC) are used. To begin the CPT, participants first immerse their hand into the warm-water bath for 2 min. Participants are then instructed to immerse their hand into the cold water bath and report when the pain becomes unbearable (pain tolerance). Lower scores indicate lower pain tolerance. Minimum score is 0 seconds, and a maximum cut-off score of 300 seconds is used to prevent tissue damage.
Outcome measures
| Measure |
Minocycline
n=10 Participants
This group received 200mg minocycline 1x/day for 15 days.
|
Placebo
n=10 Participants
This group received a placebo capsule 1x/day for 15 days.
|
|---|---|---|
|
Pain Tolerance
Baseline
|
40.86 seconds
Standard Deviation 21.71
|
59.72 seconds
Standard Deviation 30.4
|
|
Pain Tolerance
Day 8 (Test Day 1)
|
37.42 seconds
Standard Deviation 12.76
|
52.56 seconds
Standard Deviation 28.54
|
|
Pain Tolerance
Day 15 (Test Day 2)
|
34.41 seconds
Standard Deviation 11.84
|
48.42 seconds
Standard Deviation 36.62
|
|
Pain Tolerance
Day 22 (Test Day 3)
|
36.61 seconds
Standard Deviation 20.45
|
51.52 seconds
Standard Deviation 37.53
|
|
Pain Tolerance
~Day 28 (Follow-up)
|
31.58 seconds
Standard Deviation 12.56
|
43.14 seconds
Standard Deviation 15.46
|
SECONDARY outcome
Timeframe: One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)Brief Pain Inventory - Short Form: BPI-SF is a self-report questionnaire that assesses the impact of pain on daily function, location of pain, pain medications, and amount of pain relief in the past 24 hours or the past week. Each question is scored 0-10, and the scores are summed and then averaged to create a pain severity score. Minimum score is 0; maximum score is 10. Higher scores indicate more severely perceived pain.
Outcome measures
| Measure |
Minocycline
n=10 Participants
This group received 200mg minocycline 1x/day for 15 days.
|
Placebo
n=10 Participants
This group received a placebo capsule 1x/day for 15 days.
|
|---|---|---|
|
Brief Pain Inventory - Short Form: Pain Severity
Baseline
|
1.28 score on a scale
Standard Deviation 1.83
|
1.10 score on a scale
Standard Deviation 1.93
|
|
Brief Pain Inventory - Short Form: Pain Severity
Day 8 (Test Day 1)
|
0.88 score on a scale
Standard Deviation 1.56
|
0.95 score on a scale
Standard Deviation 1.96
|
|
Brief Pain Inventory - Short Form: Pain Severity
Day 15 (Test Day 2)
|
0.78 score on a scale
Standard Deviation 1.27
|
1.00 score on a scale
Standard Deviation 1.81
|
|
Brief Pain Inventory - Short Form: Pain Severity
Day 22 (Test Day 3)
|
0.80 score on a scale
Standard Deviation 1.30
|
1.18 score on a scale
Standard Deviation 2.66
|
|
Brief Pain Inventory - Short Form: Pain Severity
~Day 28 (Follow-up)
|
1.10 score on a scale
Standard Deviation 1.45
|
1.28 score on a scale
Standard Deviation 2.57
|
SECONDARY outcome
Timeframe: One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)Brief Pain Inventory - Short Form: BPI-SF is a self-report questionnaire that assesses 7 questions each rated on a scale of 0-10, which are added and divided by 7. This average score of 7 questions gives a "pain interference with living" score, with a minimum score of 0 and a maximum score of 10. Higher scores indicate that pain interferes more with aspects of daily life.
Outcome measures
| Measure |
Minocycline
n=10 Participants
This group received 200mg minocycline 1x/day for 15 days.
|
Placebo
n=10 Participants
This group received a placebo capsule 1x/day for 15 days.
|
|---|---|---|
|
Brief Pain Inventory - Short Form: Interference
Baseline
|
0.93 score on a scale
Standard Deviation 1.74
|
0.97 score on a scale
Standard Deviation 2.37
|
|
Brief Pain Inventory - Short Form: Interference
Day 8 (Test Day 1)
|
0.90 score on a scale
Standard Deviation 1.69
|
1.33 score on a scale
Standard Deviation 2.07
|
|
Brief Pain Inventory - Short Form: Interference
Day 15 (Test Day 2)
|
0.63 score on a scale
Standard Deviation 1.23
|
1.04 score on a scale
Standard Deviation 2.15
|
|
Brief Pain Inventory - Short Form: Interference
Day 22 (Test Day 3)
|
0.67 score on a scale
Standard Deviation 1.30
|
1.49 score on a scale
Standard Deviation 2.57
|
|
Brief Pain Inventory - Short Form: Interference
~Day 28 (Follow-up)
|
0.52 score on a scale
Standard Deviation 0.89
|
1.2 score on a scale
Standard Deviation 2.57
|
SECONDARY outcome
Timeframe: One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)For safety reasons, withdrawal signs and symptoms were assessed using a 22-item withdrawal instrument that has been reliably used to assess opiate withdrawal. As an additional assessment of daily pain, the presence of "back pain" item was analyzed. This item has a minimum score of 0 and maximum score of 4, with higher scores indicates more agreement with statement/more back pain.
Outcome measures
| Measure |
Minocycline
n=10 Participants
This group received 200mg minocycline 1x/day for 15 days.
|
Placebo
n=10 Participants
This group received a placebo capsule 1x/day for 15 days.
|
|---|---|---|
|
Opioid Withdrawal Symptom Checklist (OWSC): Back Pain Item
Baseline
|
0 score on a scale
Standard Deviation 0
|
0.10 score on a scale
Standard Deviation 0.32
|
|
Opioid Withdrawal Symptom Checklist (OWSC): Back Pain Item
Day 8 (Test Day 1)
|
0 score on a scale
Standard Deviation 0
|
0.10 score on a scale
Standard Deviation 0.7
|
|
Opioid Withdrawal Symptom Checklist (OWSC): Back Pain Item
Day 15 (Test Day 2)
|
0.10 score on a scale
Standard Deviation 0.32
|
0.20 score on a scale
Standard Deviation 0.63
|
|
Opioid Withdrawal Symptom Checklist (OWSC): Back Pain Item
Day 22 (Test Day 3)
|
0.20 score on a scale
Standard Deviation 0.42
|
0.20 score on a scale
Standard Deviation 0.63
|
|
Opioid Withdrawal Symptom Checklist (OWSC): Back Pain Item
~Day 28 (Follow-up)
|
0.10 score on a scale
Standard Deviation 0.32
|
0.40 score on a scale
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)The POMS is a 65-item scale that divides items amongst eight mood states (tension, depression, anger, fatigue, confusion, vigor) on a 5-point rating scale (0=not at all to 5=extremely). We analyzed the 15-item "Depression" subscale, which has a minimum score of 0 and a maximum score of 75. Higher score indicate more agreement with the statement/more feelings of depression.
Outcome measures
| Measure |
Minocycline
n=10 Participants
This group received 200mg minocycline 1x/day for 15 days.
|
Placebo
n=10 Participants
This group received a placebo capsule 1x/day for 15 days.
|
|---|---|---|
|
Profile of Mood States (POMS) Depression Subscale
Baseline
|
20.80 score on a scale
Standard Deviation 5.33
|
18.9 score on a scale
Standard Deviation 5.22
|
|
Profile of Mood States (POMS) Depression Subscale
Day 8 (Test Day 1)
|
18.9 score on a scale
Standard Deviation 5.22
|
17.9 score on a scale
Standard Deviation 3.35
|
|
Profile of Mood States (POMS) Depression Subscale
Day 15 (Test Day 2)
|
21.00 score on a scale
Standard Deviation 6.46
|
16.7 score on a scale
Standard Deviation 3.71
|
|
Profile of Mood States (POMS) Depression Subscale
Day 22 (Test Day 3)
|
19.2 score on a scale
Standard Deviation 5.43
|
17.0 score on a scale
Standard Deviation 5.01
|
|
Profile of Mood States (POMS) Depression Subscale
~Day 28 (Follow-up)
|
18.8 score on a scale
Standard Deviation 7.57
|
17.8 score on a scale
Standard Deviation 7.87
|
SECONDARY outcome
Timeframe: One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)The POMS is a 65-item scale that divides items amongst eight mood states (tension, depression, anger, fatigue, confusion, vigor) on a 5-point rating scale (0=not at all to 5=extremely). Total Mood Disturbance is calculated by adding the "tension, depression, anger, fatigue, and confusion" subscale scores and subtracting the "vigor" subscale score. This has a minimum of 0 and a maximum score of 210. Higher score indicate more mood disturbance.
Outcome measures
| Measure |
Minocycline
n=10 Participants
This group received 200mg minocycline 1x/day for 15 days.
|
Placebo
n=10 Participants
This group received a placebo capsule 1x/day for 15 days.
|
|---|---|---|
|
Profile of Mood States (POMS) - Total Mood Disturbance
Baseline
|
43.1 score on a scale
Standard Deviation 15.04
|
47.4 score on a scale
Standard Deviation 22.63
|
|
Profile of Mood States (POMS) - Total Mood Disturbance
Day 8 (Test Day 1)
|
44.7 score on a scale
Standard Deviation 14.43
|
41.88 score on a scale
Standard Deviation 13.62
|
|
Profile of Mood States (POMS) - Total Mood Disturbance
Day 15 (Test Day 2)
|
50.3 score on a scale
Standard Deviation 18.29
|
40.4 score on a scale
Standard Deviation 15.38
|
|
Profile of Mood States (POMS) - Total Mood Disturbance
Day 22 (Test Day 3)
|
43.4 score on a scale
Standard Deviation 17.51
|
42.3 score on a scale
Standard Deviation 17.51
|
|
Profile of Mood States (POMS) - Total Mood Disturbance
~Day 28 (Follow-up)
|
40.7 score on a scale
Standard Deviation 15.52
|
42.2 score on a scale
Standard Deviation 23.61
|
SECONDARY outcome
Timeframe: One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)This measure is a subscale of the SF-MPQ, comprised of 11 of the 15 total items. The measure is completed immediately after the CPT, where participants describe their experience of CPT pain by choosing among a series of possible answers \[none (score=0), mild (score=1), moderate (score=2), or severe (score=3)\]. The items to describe the pain are 'Throbbing','Shooting', 'Stabbing', 'Sharp', 'Cramping', 'Gnawing', 'Hot/burning', 'Aching', 'Heavy', 'Tender', and 'Splitting'. The scores for these 11 items are summed as a measure of Sensory pain, with a minimum score of 0 and a maximum score of 33.
Outcome measures
| Measure |
Minocycline
n=10 Participants
This group received 200mg minocycline 1x/day for 15 days.
|
Placebo
n=10 Participants
This group received a placebo capsule 1x/day for 15 days.
|
|---|---|---|
|
Short-Form McGill Pain Questionnaire (SF-MPQ): Sensory Subscale
Baseline
|
10.33 score on a scale
Standard Deviation 7.88
|
12.9 score on a scale
Standard Deviation 8.69
|
|
Short-Form McGill Pain Questionnaire (SF-MPQ): Sensory Subscale
Day 8 (Test Day 1)
|
10.9 score on a scale
Standard Deviation 8.32
|
13.1 score on a scale
Standard Deviation 4.77
|
|
Short-Form McGill Pain Questionnaire (SF-MPQ): Sensory Subscale
Day 15 (Test Day 2)
|
10.8 score on a scale
Standard Deviation 7.54
|
14.2 score on a scale
Standard Deviation 11.05
|
|
Short-Form McGill Pain Questionnaire (SF-MPQ): Sensory Subscale
Day 22 (Test Day 3)
|
11.3 score on a scale
Standard Deviation 8.26
|
13.3 score on a scale
Standard Deviation 9.44
|
|
Short-Form McGill Pain Questionnaire (SF-MPQ): Sensory Subscale
~Day 28 (Follow-up)
|
12.5 score on a scale
Standard Deviation 7.8
|
10.7 score on a scale
Standard Deviation 8.82
|
SECONDARY outcome
Timeframe: One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)This measure is a subscale of the SF-MPQ, comprised of 4 of the 15 total items. The measure is completed immediately after the CPT, where participants describe their experience of CPT pain by choosing among a series of possible answers \[none (score=0), mild (score=1), moderate (score=2), or severe (score=3)\]. The items to describe the pain are 'Tiring-Exhausting', 'Sickening', 'Fearful', 'Punishing-Cruel'. The scores for these 4 items are summed as a measure of Affective pain, with a minimum score of 0 and a maximum score of 12.
Outcome measures
| Measure |
Minocycline
n=10 Participants
This group received 200mg minocycline 1x/day for 15 days.
|
Placebo
n=10 Participants
This group received a placebo capsule 1x/day for 15 days.
|
|---|---|---|
|
Short-Form McGill Pain Questionnaire (SF-MPQ): Affective Subscale
Baseline
|
2.0 score on a scale
Standard Deviation 3.32
|
1.5 score on a scale
Standard Deviation 2.22
|
|
Short-Form McGill Pain Questionnaire (SF-MPQ): Affective Subscale
Day 8 (Test Day 1)
|
1.7 score on a scale
Standard Deviation 2.11
|
1.7 score on a scale
Standard Deviation 2.11
|
|
Short-Form McGill Pain Questionnaire (SF-MPQ): Affective Subscale
Day 15 (Test Day 2)
|
1.9 score on a scale
Standard Deviation 3.45
|
2.2 score on a scale
Standard Deviation 3.74
|
|
Short-Form McGill Pain Questionnaire (SF-MPQ): Affective Subscale
Day 22 (Test Day 3)
|
2.4 score on a scale
Standard Deviation 3.24
|
2.0 score on a scale
Standard Deviation 3.74
|
|
Short-Form McGill Pain Questionnaire (SF-MPQ): Affective Subscale
~Day 28 (Follow-up)
|
1.89 score on a scale
Standard Deviation 3.48
|
2.3 score on a scale
Standard Deviation 4.22
|
SECONDARY outcome
Timeframe: Pre/post : At Screening before medication, and on Day 22 of medicationSerum cytokine analysis assayed using electrochemiluminescence multi-array technology (Meso Scale Discovery, Gaithersburg, MD). IL-1β is measured in pictograms per milliliter (pg/ml). Cytokines were assessed at screening (approximately 1 week prior to medication), and on the last day of medication treatment. Higher numbers indicate higher blood levels of this cytokine.
Outcome measures
| Measure |
Minocycline
n=10 Participants
This group received 200mg minocycline 1x/day for 15 days.
|
Placebo
n=10 Participants
This group received a placebo capsule 1x/day for 15 days.
|
|---|---|---|
|
Interleukin-1 Beta (IL-1β)
Screening
|
0.80 pictograms per milliliter
Standard Deviation 0.58
|
0.72 pictograms per milliliter
Standard Deviation 0.55
|
|
Interleukin-1 Beta (IL-1β)
Day 22
|
0.67 pictograms per milliliter
Standard Deviation 0.44
|
0.62 pictograms per milliliter
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: Pre/post : At Screening before medication, and on Day 22 of medicationSerum cytokine analysis assayed using electrochemiluminescence multi-array technology (Meso Scale Discovery, Gaithersburg, MD). IL-6 is measured in pictograms per milliliter (pg/ml).Cytokines were assessed at screening (approximately 1 week prior to medication), and on the last day of medication treatment. Higher numbers indicate higher blood levels of this cytokine.
Outcome measures
| Measure |
Minocycline
n=10 Participants
This group received 200mg minocycline 1x/day for 15 days.
|
Placebo
n=10 Participants
This group received a placebo capsule 1x/day for 15 days.
|
|---|---|---|
|
Interleukin-6 (IL-6)
Screening
|
1.64 pictograms per milliliter
Standard Deviation 1.30
|
1.11 pictograms per milliliter
Standard Deviation 0.94
|
|
Interleukin-6 (IL-6)
Day 22
|
2.14 pictograms per milliliter
Standard Deviation 1.63
|
1.99 pictograms per milliliter
Standard Deviation 2.53
|
SECONDARY outcome
Timeframe: Pre/post : At Screening before medication, and on Day 22 of medicationSerum cytokine analysis assayed using electrochemiluminescence multi-array technology (Meso Scale Discovery, Gaithersburg, MD). TNF-α is measured in pictograms per milliliter (pg/ml).Cytokines were assessed at screening (approximately 1 week prior to medication), and on the last day of medication treatment. Higher numbers indicate higher blood levels of this cytokine.
Outcome measures
| Measure |
Minocycline
n=10 Participants
This group received 200mg minocycline 1x/day for 15 days.
|
Placebo
n=10 Participants
This group received a placebo capsule 1x/day for 15 days.
|
|---|---|---|
|
Tumor Necrosis Factor Alpha (TNF-α)
Screening
|
2.86 pictograms per milliliter
Standard Deviation 1.79
|
2.66 pictograms per milliliter
Standard Deviation 0.80
|
|
Tumor Necrosis Factor Alpha (TNF-α)
Day 22
|
2.66 pictograms per milliliter
Standard Deviation 0.80
|
2.53 pictograms per milliliter
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: 4x/day for one weekParticipants will be asked "Do you feel any pain at this moment" on seven-point Likert scales (1=strongly disagree to 7=strongly agree) 4 times per day outside of the laboratory (in their natural environment) using a personal digital assistant on days 8-14 of medication treatment. All scores were averaged to compute one score. Higher scores indicate more feelings of pain.
Outcome measures
| Measure |
Minocycline
n=10 Participants
This group received 200mg minocycline 1x/day for 15 days.
|
Placebo
n=10 Participants
This group received a placebo capsule 1x/day for 15 days.
|
|---|---|---|
|
Ecological Momentary Assessments (EMA) - Pain
|
1.22 score on a scale
Standard Deviation 0.63
|
1.14 score on a scale
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: 4x/day for one weekParticipants will be asked "Are you craving heroin at this moment" on seven-point Likert scales (1=strongly disagree to 7=strongly agree) 4 times per day outside of the laboratory (in their natural environment) using a personal digital assistant on days 8-14 of medication treatment. All scores were averaged to compute one score. Higher scores indicate more craving for heroin.
Outcome measures
| Measure |
Minocycline
n=10 Participants
This group received 200mg minocycline 1x/day for 15 days.
|
Placebo
n=10 Participants
This group received a placebo capsule 1x/day for 15 days.
|
|---|---|---|
|
Ecological Momentary Assessments (EMA) - Craving
|
1.04 score on a scale
Standard Deviation 0.18
|
1.14 score on a scale
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: 4x/day over one weekSelf-report opioid withdrawal scale. Withdrawal symptoms are measured on a 7-point Likert scale (1=strongly disagree, 7=strongly agree). Participants complete these ratings 4 times per day on days 8-14 of medication treatment. All scores were averaged to compute one score. Higher scores indicate more withdrawal symptoms.
Outcome measures
| Measure |
Minocycline
n=10 Participants
This group received 200mg minocycline 1x/day for 15 days.
|
Placebo
n=10 Participants
This group received a placebo capsule 1x/day for 15 days.
|
|---|---|---|
|
Ecological Momentary Assessments (EMA): SOWS
|
1.05 score on a scale
Standard Deviation 0.24
|
1.03 score on a scale
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Pre- and 1-hour post-medication treatment on Test Days 8, 15 and 22, and at Follow-up (~Day 28The DSST is a test of psychomotor performance, which measures motor persistence, sustained attention, response speed and visuomotor coordination. The task is to fill in blank spaces with the symbols that are paired with the number above the blank space as fast as possible for 90 sec. The minimum score is 0 and the maximum score is 120. Higher numbers indicate better cognitive performance.
Outcome measures
| Measure |
Minocycline
n=10 Participants
This group received 200mg minocycline 1x/day for 15 days.
|
Placebo
n=10 Participants
This group received a placebo capsule 1x/day for 15 days.
|
|---|---|---|
|
Digit Symbol Substitution Test
Baseline
|
37.11 score on a scale
Standard Deviation 8.57
|
37.11 score on a scale
Standard Deviation 9.05
|
|
Digit Symbol Substitution Test
Day 8 Pre-medication
|
42.33 score on a scale
Standard Deviation 8.12
|
40.89 score on a scale
Standard Deviation 4.96
|
|
Digit Symbol Substitution Test
Day 8 Post-medication
|
41.78 score on a scale
Standard Deviation 6.72
|
40.89 score on a scale
Standard Deviation 5.30
|
|
Digit Symbol Substitution Test
Day 15 Pre-medication
|
45.67 score on a scale
Standard Deviation 8.32
|
43.33 score on a scale
Standard Deviation 6.96
|
|
Digit Symbol Substitution Test
Day 15 Post-medication
|
43.25 score on a scale
Standard Deviation 11.51
|
41.11 score on a scale
Standard Deviation 7.41
|
|
Digit Symbol Substitution Test
Day 22 Pre-medication
|
48.44 score on a scale
Standard Deviation 13.38
|
43.00 score on a scale
Standard Deviation 7.23
|
|
Digit Symbol Substitution Test
Day 22 Post-medication
|
46.56 score on a scale
Standard Deviation 9.19
|
40.11 score on a scale
Standard Deviation 9.16
|
|
Digit Symbol Substitution Test
~Day 28 (Follow-up)
|
50.75 score on a scale
Standard Deviation 8.97
|
46.67 score on a scale
Standard Deviation 5.89
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Pre- and 1-hour post-medication treatment on Test Days 8, 15 and 22, and at Follow-up (~Day 28The SART is a Go No-Go task. It assesses the ability to withhold responses to an infrequently occurring target (No-Go trials). A total of 225 single digits (25 x 9 digits) are presented on a computer monitor for 250 ms each, immediately followed by a mask for 900 ms. Subjects must press a spacebar in response to every digit except the "3". Higher numbers indicate more errors of commission.
Outcome measures
| Measure |
Minocycline
n=10 Participants
This group received 200mg minocycline 1x/day for 15 days.
|
Placebo
n=10 Participants
This group received a placebo capsule 1x/day for 15 days.
|
|---|---|---|
|
Sustained Attention to Response Test (SART): No-go Trials: Errors of Commission
Day 22 Pre-medication
|
9.3 commission errors
Standard Deviation 5.58
|
7.3 commission errors
Standard Deviation 7.67
|
|
Sustained Attention to Response Test (SART): No-go Trials: Errors of Commission
Baseline
|
7 commission errors
Standard Deviation 6.41
|
9 commission errors
Standard Deviation 5.4
|
|
Sustained Attention to Response Test (SART): No-go Trials: Errors of Commission
Day 8 Pre-medication
|
5.78 commission errors
Standard Deviation 4.6
|
8.33 commission errors
Standard Deviation 6.16
|
|
Sustained Attention to Response Test (SART): No-go Trials: Errors of Commission
Day 8 Post-medication
|
5.75 commission errors
Standard Deviation 5.09
|
7.33 commission errors
Standard Deviation 5.27
|
|
Sustained Attention to Response Test (SART): No-go Trials: Errors of Commission
Day 15 Pre-medication
|
7.40 commission errors
Standard Deviation 5.76
|
7.89 commission errors
Standard Deviation 6.47
|
|
Sustained Attention to Response Test (SART): No-go Trials: Errors of Commission
Day 15 Post-medication
|
5.5 commission errors
Standard Deviation 5.8
|
8.7 commission errors
Standard Deviation 5.1
|
|
Sustained Attention to Response Test (SART): No-go Trials: Errors of Commission
Day 22 Post-medication
|
5.6 commission errors
Standard Deviation 4.78
|
9.89 commission errors
Standard Deviation 7.27
|
|
Sustained Attention to Response Test (SART): No-go Trials: Errors of Commission
~Day 28 (Follow-up)
|
7.00 commission errors
Standard Deviation 4.54
|
7.26 commission errors
Standard Deviation 6.88
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Pre- and 1-hour post-medication treatment on Test Days 8, 15 and 22, and at Follow-up (~Day 28The SART is a Go No-Go task. It assesses the ability to withhold responses to an infrequently occurring target (No-Go trials).The SART is a Go No-Go task. It assesses the ability to withhold responses to an infrequently occurring target (No-Go trials). A total of 225 single digits (25 x 9 digits) are presented on a computer monitor for 250 ms each, immediately followed by a mask for 900 ms. Subjects must press a spacebar in response to every digit except the "3". Higher numbers indicate more errors of omission.
Outcome measures
| Measure |
Minocycline
n=10 Participants
This group received 200mg minocycline 1x/day for 15 days.
|
Placebo
n=10 Participants
This group received a placebo capsule 1x/day for 15 days.
|
|---|---|---|
|
Sustained Attention to Response Test (SART): Go Trials: Errors of Omission
Baseline
|
10.9 ommission errors
Standard Deviation 8.17
|
17.9 ommission errors
Standard Deviation 16.78
|
|
Sustained Attention to Response Test (SART): Go Trials: Errors of Omission
Day 8 Pre-medication
|
9.11 ommission errors
Standard Deviation 12.67
|
13.78 ommission errors
Standard Deviation 9.93
|
|
Sustained Attention to Response Test (SART): Go Trials: Errors of Omission
Day 8 Post-medication
|
6.88 ommission errors
Standard Deviation 8.08
|
13.44 ommission errors
Standard Deviation 9.94
|
|
Sustained Attention to Response Test (SART): Go Trials: Errors of Omission
Day 15 Pre-medication
|
15.8 ommission errors
Standard Deviation 29.67
|
21 ommission errors
Standard Deviation 23.81
|
|
Sustained Attention to Response Test (SART): Go Trials: Errors of Omission
Day 15 Post-medication
|
7.7 ommission errors
Standard Deviation 12.14
|
27 ommission errors
Standard Deviation 27.87
|
|
Sustained Attention to Response Test (SART): Go Trials: Errors of Omission
Day 22 Pre-medication
|
18.4 ommission errors
Standard Deviation 18.71
|
25.4 ommission errors
Standard Deviation 30.16
|
|
Sustained Attention to Response Test (SART): Go Trials: Errors of Omission
Day 22 Post-medication
|
13.2 ommission errors
Standard Deviation 12.22
|
22.33 ommission errors
Standard Deviation 24.79
|
|
Sustained Attention to Response Test (SART): Go Trials: Errors of Omission
~Day 28 (Follow-up)
|
11.1 ommission errors
Standard Deviation 7.69
|
21.1 ommission errors
Standard Deviation 21.13
|
Adverse Events
Minocycline
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place