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Trial record 64 of 150 for:    tetracycline

The Effects of Minocycline in Opioid-maintained Patients

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ClinicalTrials.gov Identifier: NCT02359006
Recruitment Status : Completed
First Posted : February 9, 2015
Results First Posted : January 9, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Conditions Opioid Dependence
Pain
Interventions Drug: Minocycline
Drug: Placebo
Enrollment 27
Recruitment Details Fifty-five subjects were screened. Of those, 27 were deemed eligible and enrolled.
Pre-assignment Details  
Arm/Group Title Minocycline Placebo
Hide Arm/Group Description

200mg minocycline

Minocycline: Minocycline will be compared with placebo

Sugar pill

Placebo: Placebo will be compared with minocycline

Period Title: Overall Study
Started 14 13
Completed 10 10
Not Completed 4 3
Arm/Group Title Minocycline Placebo Total
Hide Arm/Group Description

200mg minocycline

Minocycline: Minocycline will be compared with placebo

Sugar pill

Placebo: Placebo will be compared with minocycline

Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
46.5  (4.5) 47.9  (10.0) 47.2  (7.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
3
  30.0%
2
  20.0%
5
  25.0%
Male
7
  70.0%
8
  80.0%
15
  75.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 10 participants 10 participants 20 participants
Black
1
  10.0%
2
  20.0%
3
  15.0%
White
7
  70.0%
6
  60.0%
13
  65.0%
Hispanic
2
  20.0%
1
  10.0%
3
  15.0%
Other
0
   0.0%
1
  10.0%
1
   5.0%
[1]
Measure Description: Subjects race and ethnicity
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Pain Threshold
Hide Description 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.
Time Frame One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline Placebo
Hide Arm/Group Description:
This group received 200mg minocycline 1x/day for 15 days.
This group received a placebo capsule 1x/day for 15 days.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: seconds
Baseline 18.72  (11.25) 24.78  (13.77)
Day 8 (Test Day 1) 16.16  (6.46) 24.37  (17.57)
Day 15 (Test Day 2) 16.13  (5.67) 18.46  (6.86)
Day 22 (Test Day 3) 16.21  (5.86) 25.75  (15.45)
~Day 28 (Follow-up) 17.59  (9.34) 21.92  (7.93)
2.Primary Outcome
Title Pain Tolerance
Hide Description 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.
Time Frame One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline Placebo
Hide Arm/Group Description:
This group received 200mg minocycline 1x/day for 15 days.
This group received a placebo capsule 1x/day for 15 days.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: seconds
Baseline 40.86  (21.71) 59.72  (30.4)
Day 8 (Test Day 1) 37.42  (12.76) 52.56  (28.54)
Day 15 (Test Day 2) 34.41  (11.84) 48.42  (36.62)
Day 22 (Test Day 3) 36.61  (20.45) 51.52  (37.53)
~Day 28 (Follow-up) 31.58  (12.56) 43.14  (15.46)
3.Secondary Outcome
Title Brief Pain Inventory – Short Form: Pain Severity
Hide Description 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.
Time Frame One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline Placebo
Hide Arm/Group Description:
This group received 200mg minocycline 1x/day for 15 days.
This group received placebo 1x/day for 15 days.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 1.28  (1.83) 1.10  (1.93)
Day 8 (Test Day 1) 0.88  (1.56) 0.95  (1.96)
Day 15 (Test Day 2) 0.78  (1.27) 1.00  (1.81)
Day 22 (Test Day 3) 0.80  (1.30) 1.18  (2.66)
~Day 28 (Follow-up) 1.10  (1.45) 1.28  (2.57)
4.Secondary Outcome
Title Brief Pain Inventory – Short Form: Interference
Hide Description

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.

Time Frame One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline Placebo
Hide Arm/Group Description:
This group received 200mg minocycline 1x/day for 15 days.
This group received placebo 1x/day for 15 days.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 0.93  (1.74) 0.97  (2.37)
Day 8 (Test Day 1) 0.90  (1.69) 1.33  (2.07)
Day 15 (Test Day 2) 0.63  (1.23) 1.04  (2.15)
Day 22 (Test Day 3) 0.67  (1.30) 1.49  (2.57)
~Day 28 (Follow-up) 0.52  (0.89) 1.2  (2.57)
5.Secondary Outcome
Title Opioid Withdrawal Symptom Checklist (OWSC): Back Pain Item
Hide Description 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.
Time Frame One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline Placebo
Hide Arm/Group Description:
This group received 200mg minocycline 1x/day for 15 days.
This group received a placebo capsule 1x/day for 15 days.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 0  (0) 0.10  (0.32)
Day 8 (Test Day 1) 0  (0) 0.10  (0.7)
Day 15 (Test Day 2) 0.10  (0.32) 0.20  (0.63)
Day 22 (Test Day 3) 0.20  (0.42) 0.20  (0.63)
~Day 28 (Follow-up) 0.10  (0.32) 0.40  (0.97)
6.Secondary Outcome
Title Profile of Mood States (POMS) Depression Subscale
Hide Description 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.
Time Frame One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline Placebo
Hide Arm/Group Description:
This group received 200mg minocycline 1x/day for 15 days.
This group received a placebo capsule 1x/day for 15 days.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 20.80  (5.33) 18.9  (5.22)
Day 8 (Test Day 1) 18.9  (5.22) 17.9  (3.35)
Day 15 (Test Day 2) 21.00  (6.46) 16.7  (3.71)
Day 22 (Test Day 3) 19.2  (5.43) 17.0  (5.01)
~Day 28 (Follow-up) 18.8  (7.57) 17.8  (7.87)
7.Secondary Outcome
Title Profile of Mood States (POMS) - Total Mood Disturbance
Hide Description 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.
Time Frame One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline Placebo
Hide Arm/Group Description:
This group received 200mg minocycline 1x/day for 15 days.
This group received placebo capsules 1x/day for 15 days.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 43.1  (15.04) 47.4  (22.63)
Day 8 (Test Day 1) 44.7  (14.43) 41.88  (13.62)
Day 15 (Test Day 2) 50.3  (18.29) 40.4  (15.38)
Day 22 (Test Day 3) 43.4  (17.51) 42.3  (17.51)
~Day 28 (Follow-up) 40.7  (15.52) 42.2  (23.61)
8.Secondary Outcome
Title Short-Form McGill Pain Questionnaire (SF-MPQ): Sensory Subscale
Hide Description 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.
Time Frame One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline Placebo
Hide Arm/Group Description:
This group received 200mg minocycline 1x/day for 15 days.
This group received placebo capsules 1x/day for 15 days.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 10.33  (7.88) 12.9  (8.69)
Day 8 (Test Day 1) 10.9  (8.32) 13.1  (4.77)
Day 15 (Test Day 2) 10.8  (7.54) 14.2  (11.05)
Day 22 (Test Day 3) 11.3  (8.26) 13.3  (9.44)
~Day 28 (Follow-up) 12.5  (7.8) 10.7  (8.82)
9.Secondary Outcome
Title Short-Form McGill Pain Questionnaire (SF-MPQ): Affective Subscale
Hide Description 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.
Time Frame One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline Placebo
Hide Arm/Group Description:
This group received 200mg minocycline 1x/day for 15 days.
This group received placebo capsules 1x/day for 15 days.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 2.0  (3.32) 1.5  (2.22)
Day 8 (Test Day 1) 1.7  (2.11) 1.7  (2.11)
Day 15 (Test Day 2) 1.9  (3.45) 2.2  (3.74)
Day 22 (Test Day 3) 2.4  (3.24) 2.0  (3.74)
~Day 28 (Follow-up) 1.89  (3.48) 2.3  (4.22)
10.Secondary Outcome
Title Interleukin-1 Beta (IL-1β)
Hide Description Serum 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.
Time Frame Pre/post : At Screening before medication, and on Day 22 of medication
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline Placebo
Hide Arm/Group Description:
This group received 200mg minocycline 1x/day for 15 days.
This group received placebo capsules 1x/day for 15 days.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: pictograms per milliliter
Screening 0.80  (0.58) 0.72  (0.55)
Day 22 0.67  (0.44) 0.62  (0.53)
11.Secondary Outcome
Title Interleukin-6 (IL-6)
Hide Description Serum 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.
Time Frame Pre/post : At Screening before medication, and on Day 22 of medication
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline Placebo
Hide Arm/Group Description:
This group received 200mg minocycline 1x/day for 15 days.
This group received placebo capsules 1x/day for 15 days.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: pictograms per milliliter
Screening 1.64  (1.30) 1.11  (0.94)
Day 22 2.14  (1.63) 1.99  (2.53)
12.Secondary Outcome
Title Tumor Necrosis Factor Alpha (TNF-α)
Hide Description Serum 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.
Time Frame Pre/post : At Screening before medication, and on Day 22 of medication
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline Placebo
Hide Arm/Group Description:
This group received 200mg minocycline 1x/day for 15 days.
This group received placebo capsules 1x/day for 15 days.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: pictograms per milliliter
Screening 2.86  (1.79) 2.66  (0.80)
Day 22 2.66  (0.80) 2.53  (0.96)
13.Secondary Outcome
Title Ecological Momentary Assessments (EMA) - Pain
Hide Description Participants 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.
Time Frame 4x/day for one week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline Placebo
Hide Arm/Group Description:
This group received 200mg minocycline 1x/day for 15 days.
This group received placebo capsules 1x/day for 15 days.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.22  (0.63) 1.14  (0.49)
14.Secondary Outcome
Title Ecological Momentary Assessments (EMA) - Craving
Hide Description Participants 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.
Time Frame 4x/day for one week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline Placebo
Hide Arm/Group Description:
This group received 200mg minocycline 1x/day for 15 days.
This group received placebo capsules 1x/day for 15 days.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.04  (0.18) 1.14  (0.49)
15.Secondary Outcome
Title Ecological Momentary Assessments (EMA): SOWS
Hide Description Self-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.
Time Frame 4x/day over one week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline Placebo
Hide Arm/Group Description:
This group received 200mg minocycline 1x/day for 15 days.
This group received placebo capsules 1x/day for 15 days.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.05  (0.24) 1.03  (0.22)
16.Secondary Outcome
Title Digit Symbol Substitution Test
Hide Description The 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.
Time Frame Baseline (Day 0), Pre- and 1-hour post-medication treatment on Test Days 8, 15 and 22, and at Follow-up (~Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline Placebo
Hide Arm/Group Description:
This group received 200mg minocycline 1x/day for 15 days.
This group received placebo capsules 1x/day for 15 days.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 37.11  (8.57) 37.11  (9.05)
Day 8 Pre-medication 42.33  (8.12) 40.89  (4.96)
Day 8 Post-medication 41.78  (6.72) 40.89  (5.30)
Day 15 Pre-medication 45.67  (8.32) 43.33  (6.96)
Day 15 Post-medication 43.25  (11.51) 41.11  (7.41)
Day 22 Pre-medication 48.44  (13.38) 43.00  (7.23)
Day 22 Post-medication 46.56  (9.19) 40.11  (9.16)
~Day 28 (Follow-up) 50.75  (8.97) 46.67  (5.89)
17.Secondary Outcome
Title Sustained Attention to Response Test (SART): No-go Trials: Errors of Commission
Hide Description 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 commission.
Time Frame Baseline (Day 0), Pre- and 1-hour post-medication treatment on Test Days 8, 15 and 22, and at Follow-up (~Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline Placebo
Hide Arm/Group Description:
This group received 200mg minocycline 1x/day for 15 days.
This group received placebo capsules 1x/day for 15 days.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: commission errors
Baseline 7  (6.41) 9  (5.4)
Day 8 Pre-medication 5.78  (4.6) 8.33  (6.16)
Day 8 Post-medication 5.75  (5.09) 7.33  (5.27)
Day 15 Pre-medication 7.40  (5.76) 7.89  (6.47)
Day 15 Post-medication 5.5  (5.8) 8.7  (5.1)
Day 22 Pre-medication 9.3  (5.58) 7.3  (7.67)
Day 22 Post-medication 5.6  (4.78) 9.89  (7.27)
~Day 28 (Follow-up) 7.00  (4.54) 7.26  (6.88)
18.Secondary Outcome
Title Sustained Attention to Response Test (SART): Go Trials: Errors of Omission
Hide Description The 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.
Time Frame Baseline (Day 0), Pre- and 1-hour post-medication treatment on Test Days 8, 15 and 22, and at Follow-up (~Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minocycline Placebo
Hide Arm/Group Description:
This group received 200mg minocycline 1x/day for 15 days.
This group received placebo capsules 1x/day for 15 days.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: ommission errors
Baseline 10.9  (8.17) 17.9  (16.78)
Day 8 Pre-medication 9.11  (12.67) 13.78  (9.93)
Day 8 Post-medication 6.88  (8.08) 13.44  (9.94)
Day 15 Pre-medication 15.8  (29.67) 21  (23.81)
Day 15 Post-medication 7.7  (12.14) 27  (27.87)
Day 22 Pre-medication 18.4  (18.71) 25.4  (30.16)
Day 22 Post-medication 13.2  (12.22) 22.33  (24.79)
~Day 28 (Follow-up) 11.1  (7.69) 21.1  (21.13)
Time Frame 4 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Minocycline Placebo
Hide Arm/Group Description

200mg minocycline

Minocycline: Minocycline will be compared with placebo

Sugar pill

Placebo: Placebo will be compared with minocycline

All-Cause Mortality
Minocycline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Minocycline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Minocycline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Mehmet Sofuoglu
Organization: Yale University
Phone: 203-932-5711 ext 4809
EMail: mehmet.sofuoglu@yale.edu
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02359006     History of Changes
Other Study ID Numbers: 1412015119
First Submitted: February 3, 2015
First Posted: February 9, 2015
Results First Submitted: November 16, 2018
Results First Posted: January 9, 2019
Last Update Posted: June 27, 2019