Trial Outcomes & Findings for St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Gabapentin (NCT NCT04052139)
NCT ID: NCT04052139
Last Updated: 2022-11-10
Results Overview
Change in past week pain severity (score 0 \[no pain\] -10 \[high pain\]) from baseline to week 8. Pain severity will be measured using the Brief Pain Inventory, which allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Baseline, 8-weeks
Results posted on
2022-11-10
Participant Flow
Participant milestones
| Measure |
Low-dose Naltrexone
Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.
Low-dose naltrexone: 4.5 mg of low dose naltrexone taken once daily for 8 weeks. In week 1, participants will take 4.5mg of naltrexone once daily. In week 2, participants will take 4.5mg of naltrexone once daily, and a placebo capsule twice daily. In weeks 3 through 7, participants will take 1 placebo capsule with 4.5 mg mg of naltrexone once daily, and 2 placebo capsules twice daily. In week 8, in days 1-4 participants will take 4.5 mg of naltrexone with a placebo capsule once daily and 2 placebo capsules twice daily; in days 5-7, participants will take 4.5 mg of naltrexone once daily, and a placebo capsule twice daily.
|
Gabapentin
Participants randomized to the gabapentin arm begin on a dose of 300 mg daily (300 mg qd). In week 2, participants will take 300 mg of gabapentin three times daily. In week 3 the dose will be titrated up to 1800 mg daily (300 mg+300 mg tid) will remain on the dose until week 8, when they will be tapered back down to 900 mg daily (300 mg tid). In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
Gabapentin: Dose will begin at 300 mg daily (300 mg qd), in week 2 the dose will be titrated up to 900 mg daily (300 mg tid). In week 3, the dose will be titrated to 1800 mg daily ( 2 capsules of 300 mg tid) and participants will remain on that dose until week 8. In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
|
Placebo
Participants will receive a placebo to be taken three times daily for 8 weeks.
Placebo: In week 1, participants will take 1 placebo capsule once daily. In week 2, participants will take 1 placebo capsule three times per day. In weeks 3 through 7, 2 placebo capsules three times per day. In week 8, in days 1-4 participants will take 2 placebo capsules three times per day; in days 5-7, participants will take 1 placebo capsule three times per day. The placebo medications will be composed of lactose and will not contain active ingredients.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
|
Overall Study
4-weeks
|
14
|
15
|
15
|
|
Overall Study
8-weeks
|
12
|
15
|
15
|
|
Overall Study
12-weeks
|
12
|
15
|
15
|
|
Overall Study
COMPLETED
|
12
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
Low-dose Naltrexone
Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.
Low-dose naltrexone: 4.5 mg of low dose naltrexone taken once daily for 8 weeks. In week 1, participants will take 4.5mg of naltrexone once daily. In week 2, participants will take 4.5mg of naltrexone once daily, and a placebo capsule twice daily. In weeks 3 through 7, participants will take 1 placebo capsule with 4.5 mg mg of naltrexone once daily, and 2 placebo capsules twice daily. In week 8, in days 1-4 participants will take 4.5 mg of naltrexone with a placebo capsule once daily and 2 placebo capsules twice daily; in days 5-7, participants will take 4.5 mg of naltrexone once daily, and a placebo capsule twice daily.
|
Gabapentin
Participants randomized to the gabapentin arm begin on a dose of 300 mg daily (300 mg qd). In week 2, participants will take 300 mg of gabapentin three times daily. In week 3 the dose will be titrated up to 1800 mg daily (300 mg+300 mg tid) will remain on the dose until week 8, when they will be tapered back down to 900 mg daily (300 mg tid). In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
Gabapentin: Dose will begin at 300 mg daily (300 mg qd), in week 2 the dose will be titrated up to 900 mg daily (300 mg tid). In week 3, the dose will be titrated to 1800 mg daily ( 2 capsules of 300 mg tid) and participants will remain on that dose until week 8. In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
|
Placebo
Participants will receive a placebo to be taken three times daily for 8 weeks.
Placebo: In week 1, participants will take 1 placebo capsule once daily. In week 2, participants will take 1 placebo capsule three times per day. In weeks 3 through 7, 2 placebo capsules three times per day. In week 8, in days 1-4 participants will take 2 placebo capsules three times per day; in days 5-7, participants will take 1 placebo capsule three times per day. The placebo medications will be composed of lactose and will not contain active ingredients.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Gabapentin
Baseline characteristics by cohort
| Measure |
Low-dose Naltrexone
n=15 Participants
Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.
Low-dose naltrexone: 4.5 mg of low dose naltrexone taken once daily for 8 weeks. In week 1, participants will take 4.5mg of naltrexone once daily. In week 2, participants will take 4.5mg of naltrexone once daily, and a placebo capsule twice daily. In weeks 3 through 7, participants will take 1 placebo capsule with 4.5 mg mg of naltrexone once daily, and 2 placebo capsules twice daily. In week 8, in days 1-4 participants will take 4.5 mg of naltrexone with a placebo capsule once daily and 2 placebo capsules twice daily; in days 5-7, participants will take 4.5 mg of naltrexone once daily, and a placebo capsule twice daily.
|
Gabapentin
n=15 Participants
Participants randomized to the gabapentin arm begin on a dose of 300 mg daily (300 mg qd). In week 2, participants will take 300 mg of gabapentin three times daily. In week 3 the dose will be titrated up to 1800 mg daily (300 mg+300 mg tid) will remain on the dose until week 8, when they will be tapered back down to 900 mg daily (300 mg tid). In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
Gabapentin: Dose will begin at 300 mg daily (300 mg qd), in week 2 the dose will be titrated up to 900 mg daily (300 mg tid). In week 3, the dose will be titrated to 1800 mg daily ( 2 capsules of 300 mg tid) and participants will remain on that dose until week 8. In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
|
Placebo
n=15 Participants
Participants will receive a placebo to be taken three times daily for 8 weeks.
Placebo: In week 1, participants will take 1 placebo capsule once daily. In week 2, participants will take 1 placebo capsule three times per day. In weeks 3 through 7, 2 placebo capsules three times per day. In week 8, in days 1-4 participants will take 2 placebo capsules three times per day; in days 5-7, participants will take 1 placebo capsule three times per day. The placebo medications will be composed of lactose and will not contain active ingredients.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 6 • n=93 Participants
|
41 years
STANDARD_DEVIATION 7 • n=4 Participants
|
41 years
STANDARD_DEVIATION 7 • n=27 Participants
|
41 years
STANDARD_DEVIATION 7 • n=483 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
29 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
45 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
45 Participants
n=483 Participants
|
|
Region of Enrollment
Russia
|
15 participants
n=93 Participants
|
15 participants
n=4 Participants
|
15 participants
n=27 Participants
|
45 participants
n=483 Participants
|
|
Education - 9 grades or more
|
15 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
45 Participants
n=483 Participants
|
|
Marital status
Married/living with partner/long-term relationship
|
5 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
|
Marital status
Never married/divorced/widowed/separated
|
10 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
23 Participants
n=483 Participants
|
|
Harmful or hazardous drinking (AUDIT)
AUDIT score <8
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
|
Harmful or hazardous drinking (AUDIT)
AUDIT score 8+
|
10 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
27 Participants
n=483 Participants
|
|
Number of heavy drinking days in past 30 days
|
2 days
STANDARD_DEVIATION 4 • n=93 Participants
|
2 days
STANDARD_DEVIATION 3 • n=4 Participants
|
2 days
STANDARD_DEVIATION 4 • n=27 Participants
|
2 days
STANDARD_DEVIATION 4 • n=483 Participants
|
|
Past month heavy drinking days (%)
|
8 % days
STANDARD_DEVIATION 14.6 • n=93 Participants
|
6.7 % days
STANDARD_DEVIATION 9.4 • n=4 Participants
|
8 % days
STANDARD_DEVIATION 14.5 • n=27 Participants
|
7.6 % days
STANDARD_DEVIATION 12.8 • n=483 Participants
|
|
Lifetime opioid use
No use of opioids in lifetime
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
|
Lifetime opioid use
Use of opioids in lifetime
|
9 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
25 Participants
n=483 Participants
|
|
Past week pain severity
|
3.2 units on a scale
STANDARD_DEVIATION 1.4 • n=93 Participants
|
3.1 units on a scale
STANDARD_DEVIATION 1.3 • n=4 Participants
|
3.3 units on a scale
STANDARD_DEVIATION 1.5 • n=27 Participants
|
3.2 units on a scale
STANDARD_DEVIATION 1.3 • n=483 Participants
|
|
Past week pain interference
|
3 units on a scale
STANDARD_DEVIATION 2 • n=93 Participants
|
3 units on a scale
STANDARD_DEVIATION 2 • n=4 Participants
|
3 units on a scale
STANDARD_DEVIATION 2 • n=27 Participants
|
3 units on a scale
STANDARD_DEVIATION 2 • n=483 Participants
|
|
Cold pain threshold
|
21 seconds
STANDARD_DEVIATION 17 • n=93 Participants
|
15 seconds
STANDARD_DEVIATION 13 • n=4 Participants
|
14 seconds
STANDARD_DEVIATION 6 • n=27 Participants
|
17 seconds
STANDARD_DEVIATION 13 • n=483 Participants
|
|
Cold pain tolerance
|
42 seconds
STANDARD_DEVIATION 33 • n=93 Participants
|
33 seconds
STANDARD_DEVIATION 25 • n=4 Participants
|
36 seconds
STANDARD_DEVIATION 41 • n=27 Participants
|
37 seconds
STANDARD_DEVIATION 33 • n=483 Participants
|
|
IL-6 biomarker
|
3.77 pg/ml
STANDARD_DEVIATION 0.66 • n=93 Participants
|
3.73 pg/ml
STANDARD_DEVIATION 0.4 • n=4 Participants
|
3.5 pg/ml
STANDARD_DEVIATION 0.38 • n=27 Participants
|
3.67 pg/ml
STANDARD_DEVIATION 0.5 • n=483 Participants
|
|
IL-10 biomarker
|
3.81 pg/ml
STANDARD_DEVIATION 0.7 • n=93 Participants
|
3.85 pg/ml
STANDARD_DEVIATION 0.7 • n=4 Participants
|
3.92 pg/ml
STANDARD_DEVIATION 0.8 • n=27 Participants
|
3.86 pg/ml
STANDARD_DEVIATION 0.7 • n=483 Participants
|
|
TNF-alpha biomarker
|
5.70 pg/ml
STANDARD_DEVIATION 0.7 • n=93 Participants
|
5.86 pg/ml
STANDARD_DEVIATION 0.9 • n=4 Participants
|
6.35 pg/ml
STANDARD_DEVIATION 1.2 • n=27 Participants
|
5.97 pg/ml
STANDARD_DEVIATION 1.0 • n=483 Participants
|
|
IL-1-beta biomarker
|
5.73 pg/ml
STANDARD_DEVIATION 0.5 • n=93 Participants
|
5.57 pg/ml
STANDARD_DEVIATION 0.7 • n=4 Participants
|
5.53 pg/ml
STANDARD_DEVIATION 0.6 • n=27 Participants
|
5.61 pg/ml
STANDARD_DEVIATION 0.6 • n=483 Participants
|
|
HIV viral load suppression
Unsuppressed viral load
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
HIV viral load suppression
Suppressed viral load
|
12 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
41 Participants
n=483 Participants
|
|
CD4 count
|
648 cell/mm^3
STANDARD_DEVIATION 273 • n=93 Participants
|
808 cell/mm^3
STANDARD_DEVIATION 290 • n=4 Participants
|
917 cell/mm^3
STANDARD_DEVIATION 381 • n=27 Participants
|
791 cell/mm^3
STANDARD_DEVIATION 331 • n=483 Participants
|
|
Depressive symptoms
No depressive symptoms
|
12 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
36 Participants
n=483 Participants
|
|
Depressive symptoms
Depressive symptoms
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Anxiety
Minimal anxiety
|
11 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
33 Participants
n=483 Participants
|
|
Anxiety
Mild anxiety
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Anxiety
Moderate anxiety
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline, 8-weeksChange in past week pain severity (score 0 \[no pain\] -10 \[high pain\]) from baseline to week 8. Pain severity will be measured using the Brief Pain Inventory, which allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function
Outcome measures
| Measure |
Low-dose Naltrexone
n=12 Participants
Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.
Low-dose naltrexone: 4.5 mg of low dose naltrexone taken once daily for 8 weeks. In week 1, participants will take 4.5mg of naltrexone once daily. In week 2, participants will take 4.5mg of naltrexone once daily, and a placebo capsule twice daily. In weeks 3 through 7, participants will take 1 placebo capsule with 4.5 mg mg of naltrexone once daily, and 2 placebo capsules twice daily. In week 8, in days 1-4 participants will take 4.5 mg of naltrexone with a placebo capsule once daily and 2 placebo capsules twice daily; in days 5-7, participants will take 4.5 mg of naltrexone once daily, and a placebo capsule twice daily.
|
Gabapentin
n=15 Participants
Participants randomized to the gabapentin arm begin on a dose of 300 mg daily (300 mg qd). In week 2, participants will take 300 mg of gabapentin three times daily. In week 3 the dose will be titrated up to 1800 mg daily (300 mg+300 mg tid) will remain on the dose until week 8, when they will be tapered back down to 900 mg daily (300 mg tid). In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
Gabapentin: Dose will begin at 300 mg daily (300 mg qd), in week 2 the dose will be titrated up to 900 mg daily (300 mg tid). In week 3, the dose will be titrated to 1800 mg daily ( 2 capsules of 300 mg tid) and participants will remain on that dose until week 8. In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
|
Placebo
n=15 Participants
Participants will receive a placebo to be taken three times daily for 8 weeks.
Placebo: In week 1, participants will take 1 placebo capsule once daily. In week 2, participants will take 1 placebo capsule three times per day. In weeks 3 through 7, 2 placebo capsules three times per day. In week 8, in days 1-4 participants will take 2 placebo capsules three times per day; in days 5-7, participants will take 1 placebo capsule three times per day. The placebo medications will be composed of lactose and will not contain active ingredients.
|
|---|---|---|---|
|
Change in Past Week Pain Severity
|
-0.97 units on a scale
Standard Error 0.63
|
-2.12 units on a scale
Standard Error 0.38
|
-1.85 units on a scale
Standard Error 0.61
|
PRIMARY outcome
Timeframe: Baseline, 8-weeksChange in past week pain interference (score 0 \[no pain\]-10 \[high pain\]) from baseline to week 8. Pain interference will be measured using the Brief Pain Inventory, which allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function
Outcome measures
| Measure |
Low-dose Naltrexone
n=12 Participants
Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.
Low-dose naltrexone: 4.5 mg of low dose naltrexone taken once daily for 8 weeks. In week 1, participants will take 4.5mg of naltrexone once daily. In week 2, participants will take 4.5mg of naltrexone once daily, and a placebo capsule twice daily. In weeks 3 through 7, participants will take 1 placebo capsule with 4.5 mg mg of naltrexone once daily, and 2 placebo capsules twice daily. In week 8, in days 1-4 participants will take 4.5 mg of naltrexone with a placebo capsule once daily and 2 placebo capsules twice daily; in days 5-7, participants will take 4.5 mg of naltrexone once daily, and a placebo capsule twice daily.
|
Gabapentin
n=15 Participants
Participants randomized to the gabapentin arm begin on a dose of 300 mg daily (300 mg qd). In week 2, participants will take 300 mg of gabapentin three times daily. In week 3 the dose will be titrated up to 1800 mg daily (300 mg+300 mg tid) will remain on the dose until week 8, when they will be tapered back down to 900 mg daily (300 mg tid). In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
Gabapentin: Dose will begin at 300 mg daily (300 mg qd), in week 2 the dose will be titrated up to 900 mg daily (300 mg tid). In week 3, the dose will be titrated to 1800 mg daily ( 2 capsules of 300 mg tid) and participants will remain on that dose until week 8. In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
|
Placebo
n=15 Participants
Participants will receive a placebo to be taken three times daily for 8 weeks.
Placebo: In week 1, participants will take 1 placebo capsule once daily. In week 2, participants will take 1 placebo capsule three times per day. In weeks 3 through 7, 2 placebo capsules three times per day. In week 8, in days 1-4 participants will take 2 placebo capsules three times per day; in days 5-7, participants will take 1 placebo capsule three times per day. The placebo medications will be composed of lactose and will not contain active ingredients.
|
|---|---|---|---|
|
Change in Past Week Pain Interference
|
-1.73 units on a scale
Standard Error 0.47
|
-1.97 units on a scale
Standard Error 0.64
|
-2.14 units on a scale
Standard Error 0.58
|
SECONDARY outcome
Timeframe: Baseline, 8-weeksMean change in the number of seconds a participant can keep their hand submerged in a container of iced water. Participants were instructed to keep their hand in as long as they could, up to 3 minutes.
Outcome measures
| Measure |
Low-dose Naltrexone
n=12 Participants
Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.
Low-dose naltrexone: 4.5 mg of low dose naltrexone taken once daily for 8 weeks. In week 1, participants will take 4.5mg of naltrexone once daily. In week 2, participants will take 4.5mg of naltrexone once daily, and a placebo capsule twice daily. In weeks 3 through 7, participants will take 1 placebo capsule with 4.5 mg mg of naltrexone once daily, and 2 placebo capsules twice daily. In week 8, in days 1-4 participants will take 4.5 mg of naltrexone with a placebo capsule once daily and 2 placebo capsules twice daily; in days 5-7, participants will take 4.5 mg of naltrexone once daily, and a placebo capsule twice daily.
|
Gabapentin
n=15 Participants
Participants randomized to the gabapentin arm begin on a dose of 300 mg daily (300 mg qd). In week 2, participants will take 300 mg of gabapentin three times daily. In week 3 the dose will be titrated up to 1800 mg daily (300 mg+300 mg tid) will remain on the dose until week 8, when they will be tapered back down to 900 mg daily (300 mg tid). In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
Gabapentin: Dose will begin at 300 mg daily (300 mg qd), in week 2 the dose will be titrated up to 900 mg daily (300 mg tid). In week 3, the dose will be titrated to 1800 mg daily ( 2 capsules of 300 mg tid) and participants will remain on that dose until week 8. In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
|
Placebo
n=15 Participants
Participants will receive a placebo to be taken three times daily for 8 weeks.
Placebo: In week 1, participants will take 1 placebo capsule once daily. In week 2, participants will take 1 placebo capsule three times per day. In weeks 3 through 7, 2 placebo capsules three times per day. In week 8, in days 1-4 participants will take 2 placebo capsules three times per day; in days 5-7, participants will take 1 placebo capsule three times per day. The placebo medications will be composed of lactose and will not contain active ingredients.
|
|---|---|---|---|
|
Change in Cold Pain Tolerance
|
-14.78 seconds
Standard Error 7.61
|
-3.33 seconds
Standard Error 4.56
|
-3.15 seconds
Standard Error 6.89
|
SECONDARY outcome
Timeframe: Baseline, 8-weeksMean percentage of change in self-reported heavy drinking in the past 30 days of alcohol consumption obtained via the Timeline Followback (TLFB) method. The NIAAA definition of heavy drinking is used (\> 4 drinks in a day for men; \> 3 drinks in a day for women). Participants were asked about their alcohol consumption on each day in the previous 30 days.
Outcome measures
| Measure |
Low-dose Naltrexone
n=12 Participants
Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.
Low-dose naltrexone: 4.5 mg of low dose naltrexone taken once daily for 8 weeks. In week 1, participants will take 4.5mg of naltrexone once daily. In week 2, participants will take 4.5mg of naltrexone once daily, and a placebo capsule twice daily. In weeks 3 through 7, participants will take 1 placebo capsule with 4.5 mg mg of naltrexone once daily, and 2 placebo capsules twice daily. In week 8, in days 1-4 participants will take 4.5 mg of naltrexone with a placebo capsule once daily and 2 placebo capsules twice daily; in days 5-7, participants will take 4.5 mg of naltrexone once daily, and a placebo capsule twice daily.
|
Gabapentin
n=15 Participants
Participants randomized to the gabapentin arm begin on a dose of 300 mg daily (300 mg qd). In week 2, participants will take 300 mg of gabapentin three times daily. In week 3 the dose will be titrated up to 1800 mg daily (300 mg+300 mg tid) will remain on the dose until week 8, when they will be tapered back down to 900 mg daily (300 mg tid). In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
Gabapentin: Dose will begin at 300 mg daily (300 mg qd), in week 2 the dose will be titrated up to 900 mg daily (300 mg tid). In week 3, the dose will be titrated to 1800 mg daily ( 2 capsules of 300 mg tid) and participants will remain on that dose until week 8. In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
|
Placebo
n=15 Participants
Participants will receive a placebo to be taken three times daily for 8 weeks.
Placebo: In week 1, participants will take 1 placebo capsule once daily. In week 2, participants will take 1 placebo capsule three times per day. In weeks 3 through 7, 2 placebo capsules three times per day. In week 8, in days 1-4 participants will take 2 placebo capsules three times per day; in days 5-7, participants will take 1 placebo capsule three times per day. The placebo medications will be composed of lactose and will not contain active ingredients.
|
|---|---|---|---|
|
Change in Percentage of Past Month Heavy Drinking Days
|
3.07 % of change in heavy drinking days
Standard Error 5.17
|
-4.22 % of change in heavy drinking days
Standard Error 2.07
|
-4.63 % of change in heavy drinking days
Standard Error 4.64
|
SECONDARY outcome
Timeframe: Baseline, 8-weeksDefined as mean change in CD4 values from lab assay
Outcome measures
| Measure |
Low-dose Naltrexone
n=12 Participants
Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.
Low-dose naltrexone: 4.5 mg of low dose naltrexone taken once daily for 8 weeks. In week 1, participants will take 4.5mg of naltrexone once daily. In week 2, participants will take 4.5mg of naltrexone once daily, and a placebo capsule twice daily. In weeks 3 through 7, participants will take 1 placebo capsule with 4.5 mg mg of naltrexone once daily, and 2 placebo capsules twice daily. In week 8, in days 1-4 participants will take 4.5 mg of naltrexone with a placebo capsule once daily and 2 placebo capsules twice daily; in days 5-7, participants will take 4.5 mg of naltrexone once daily, and a placebo capsule twice daily.
|
Gabapentin
n=15 Participants
Participants randomized to the gabapentin arm begin on a dose of 300 mg daily (300 mg qd). In week 2, participants will take 300 mg of gabapentin three times daily. In week 3 the dose will be titrated up to 1800 mg daily (300 mg+300 mg tid) will remain on the dose until week 8, when they will be tapered back down to 900 mg daily (300 mg tid). In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
Gabapentin: Dose will begin at 300 mg daily (300 mg qd), in week 2 the dose will be titrated up to 900 mg daily (300 mg tid). In week 3, the dose will be titrated to 1800 mg daily ( 2 capsules of 300 mg tid) and participants will remain on that dose until week 8. In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
|
Placebo
n=15 Participants
Participants will receive a placebo to be taken three times daily for 8 weeks.
Placebo: In week 1, participants will take 1 placebo capsule once daily. In week 2, participants will take 1 placebo capsule three times per day. In weeks 3 through 7, 2 placebo capsules three times per day. In week 8, in days 1-4 participants will take 2 placebo capsules three times per day; in days 5-7, participants will take 1 placebo capsule three times per day. The placebo medications will be composed of lactose and will not contain active ingredients.
|
|---|---|---|---|
|
Change in CD4 Count
|
15.85 cell/mm^3
Standard Error 74.96
|
-106.47 cell/mm^3
Standard Error 64.94
|
-52.13 cell/mm^3
Standard Error 82.43
|
SECONDARY outcome
Timeframe: Baseline, 8-weeksDefined as number of participants who change from suppressed to unsuppressed or unsuppressed to suppressed from lab tests
Outcome measures
| Measure |
Low-dose Naltrexone
n=12 Participants
Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.
Low-dose naltrexone: 4.5 mg of low dose naltrexone taken once daily for 8 weeks. In week 1, participants will take 4.5mg of naltrexone once daily. In week 2, participants will take 4.5mg of naltrexone once daily, and a placebo capsule twice daily. In weeks 3 through 7, participants will take 1 placebo capsule with 4.5 mg mg of naltrexone once daily, and 2 placebo capsules twice daily. In week 8, in days 1-4 participants will take 4.5 mg of naltrexone with a placebo capsule once daily and 2 placebo capsules twice daily; in days 5-7, participants will take 4.5 mg of naltrexone once daily, and a placebo capsule twice daily.
|
Gabapentin
n=15 Participants
Participants randomized to the gabapentin arm begin on a dose of 300 mg daily (300 mg qd). In week 2, participants will take 300 mg of gabapentin three times daily. In week 3 the dose will be titrated up to 1800 mg daily (300 mg+300 mg tid) will remain on the dose until week 8, when they will be tapered back down to 900 mg daily (300 mg tid). In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
Gabapentin: Dose will begin at 300 mg daily (300 mg qd), in week 2 the dose will be titrated up to 900 mg daily (300 mg tid). In week 3, the dose will be titrated to 1800 mg daily ( 2 capsules of 300 mg tid) and participants will remain on that dose until week 8. In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
|
Placebo
n=15 Participants
Participants will receive a placebo to be taken three times daily for 8 weeks.
Placebo: In week 1, participants will take 1 placebo capsule once daily. In week 2, participants will take 1 placebo capsule three times per day. In weeks 3 through 7, 2 placebo capsules three times per day. In week 8, in days 1-4 participants will take 2 placebo capsules three times per day; in days 5-7, participants will take 1 placebo capsule three times per day. The placebo medications will be composed of lactose and will not contain active ingredients.
|
|---|---|---|---|
|
Number of Participants With a Change in HIV Viral Load Suppression Status
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 8-weeksMean change in IL-6 values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R\&D Systems).
Outcome measures
| Measure |
Low-dose Naltrexone
n=12 Participants
Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.
Low-dose naltrexone: 4.5 mg of low dose naltrexone taken once daily for 8 weeks. In week 1, participants will take 4.5mg of naltrexone once daily. In week 2, participants will take 4.5mg of naltrexone once daily, and a placebo capsule twice daily. In weeks 3 through 7, participants will take 1 placebo capsule with 4.5 mg mg of naltrexone once daily, and 2 placebo capsules twice daily. In week 8, in days 1-4 participants will take 4.5 mg of naltrexone with a placebo capsule once daily and 2 placebo capsules twice daily; in days 5-7, participants will take 4.5 mg of naltrexone once daily, and a placebo capsule twice daily.
|
Gabapentin
n=15 Participants
Participants randomized to the gabapentin arm begin on a dose of 300 mg daily (300 mg qd). In week 2, participants will take 300 mg of gabapentin three times daily. In week 3 the dose will be titrated up to 1800 mg daily (300 mg+300 mg tid) will remain on the dose until week 8, when they will be tapered back down to 900 mg daily (300 mg tid). In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
Gabapentin: Dose will begin at 300 mg daily (300 mg qd), in week 2 the dose will be titrated up to 900 mg daily (300 mg tid). In week 3, the dose will be titrated to 1800 mg daily ( 2 capsules of 300 mg tid) and participants will remain on that dose until week 8. In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
|
Placebo
n=15 Participants
Participants will receive a placebo to be taken three times daily for 8 weeks.
Placebo: In week 1, participants will take 1 placebo capsule once daily. In week 2, participants will take 1 placebo capsule three times per day. In weeks 3 through 7, 2 placebo capsules three times per day. In week 8, in days 1-4 participants will take 2 placebo capsules three times per day; in days 5-7, participants will take 1 placebo capsule three times per day. The placebo medications will be composed of lactose and will not contain active ingredients.
|
|---|---|---|---|
|
Change in Biomarker IL-6
|
-0.12 pg/ml
Standard Error 0.19
|
0.04 pg/ml
Standard Error 0.12
|
0.29 pg/ml
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksMean change in IL-10 values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R\&D Systems).
Outcome measures
| Measure |
Low-dose Naltrexone
n=12 Participants
Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.
Low-dose naltrexone: 4.5 mg of low dose naltrexone taken once daily for 8 weeks. In week 1, participants will take 4.5mg of naltrexone once daily. In week 2, participants will take 4.5mg of naltrexone once daily, and a placebo capsule twice daily. In weeks 3 through 7, participants will take 1 placebo capsule with 4.5 mg mg of naltrexone once daily, and 2 placebo capsules twice daily. In week 8, in days 1-4 participants will take 4.5 mg of naltrexone with a placebo capsule once daily and 2 placebo capsules twice daily; in days 5-7, participants will take 4.5 mg of naltrexone once daily, and a placebo capsule twice daily.
|
Gabapentin
n=15 Participants
Participants randomized to the gabapentin arm begin on a dose of 300 mg daily (300 mg qd). In week 2, participants will take 300 mg of gabapentin three times daily. In week 3 the dose will be titrated up to 1800 mg daily (300 mg+300 mg tid) will remain on the dose until week 8, when they will be tapered back down to 900 mg daily (300 mg tid). In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
Gabapentin: Dose will begin at 300 mg daily (300 mg qd), in week 2 the dose will be titrated up to 900 mg daily (300 mg tid). In week 3, the dose will be titrated to 1800 mg daily ( 2 capsules of 300 mg tid) and participants will remain on that dose until week 8. In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
|
Placebo
n=15 Participants
Participants will receive a placebo to be taken three times daily for 8 weeks.
Placebo: In week 1, participants will take 1 placebo capsule once daily. In week 2, participants will take 1 placebo capsule three times per day. In weeks 3 through 7, 2 placebo capsules three times per day. In week 8, in days 1-4 participants will take 2 placebo capsules three times per day; in days 5-7, participants will take 1 placebo capsule three times per day. The placebo medications will be composed of lactose and will not contain active ingredients.
|
|---|---|---|---|
|
Change in Biomarker IL-10
|
-0.13 pg/ml
Standard Error 0.25
|
0.07 pg/ml
Standard Error 0.16
|
-0.26 pg/ml
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Baseline, 8-weeksMean change in TNF-alpha values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R\&D Systems).
Outcome measures
| Measure |
Low-dose Naltrexone
n=12 Participants
Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.
Low-dose naltrexone: 4.5 mg of low dose naltrexone taken once daily for 8 weeks. In week 1, participants will take 4.5mg of naltrexone once daily. In week 2, participants will take 4.5mg of naltrexone once daily, and a placebo capsule twice daily. In weeks 3 through 7, participants will take 1 placebo capsule with 4.5 mg mg of naltrexone once daily, and 2 placebo capsules twice daily. In week 8, in days 1-4 participants will take 4.5 mg of naltrexone with a placebo capsule once daily and 2 placebo capsules twice daily; in days 5-7, participants will take 4.5 mg of naltrexone once daily, and a placebo capsule twice daily.
|
Gabapentin
n=15 Participants
Participants randomized to the gabapentin arm begin on a dose of 300 mg daily (300 mg qd). In week 2, participants will take 300 mg of gabapentin three times daily. In week 3 the dose will be titrated up to 1800 mg daily (300 mg+300 mg tid) will remain on the dose until week 8, when they will be tapered back down to 900 mg daily (300 mg tid). In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
Gabapentin: Dose will begin at 300 mg daily (300 mg qd), in week 2 the dose will be titrated up to 900 mg daily (300 mg tid). In week 3, the dose will be titrated to 1800 mg daily ( 2 capsules of 300 mg tid) and participants will remain on that dose until week 8. In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
|
Placebo
n=15 Participants
Participants will receive a placebo to be taken three times daily for 8 weeks.
Placebo: In week 1, participants will take 1 placebo capsule once daily. In week 2, participants will take 1 placebo capsule three times per day. In weeks 3 through 7, 2 placebo capsules three times per day. In week 8, in days 1-4 participants will take 2 placebo capsules three times per day; in days 5-7, participants will take 1 placebo capsule three times per day. The placebo medications will be composed of lactose and will not contain active ingredients.
|
|---|---|---|---|
|
Change in TNF-alpha
|
0.27 pg/ml
Standard Error 0.31
|
0.47 pg/ml
Standard Error 0.15
|
0.21 pg/ml
Standard Error 0.42
|
SECONDARY outcome
Timeframe: Baseline, 8-weeksMean change in IL-1beta values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R\&D Systems).
Outcome measures
| Measure |
Low-dose Naltrexone
n=12 Participants
Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.
Low-dose naltrexone: 4.5 mg of low dose naltrexone taken once daily for 8 weeks. In week 1, participants will take 4.5mg of naltrexone once daily. In week 2, participants will take 4.5mg of naltrexone once daily, and a placebo capsule twice daily. In weeks 3 through 7, participants will take 1 placebo capsule with 4.5 mg mg of naltrexone once daily, and 2 placebo capsules twice daily. In week 8, in days 1-4 participants will take 4.5 mg of naltrexone with a placebo capsule once daily and 2 placebo capsules twice daily; in days 5-7, participants will take 4.5 mg of naltrexone once daily, and a placebo capsule twice daily.
|
Gabapentin
n=15 Participants
Participants randomized to the gabapentin arm begin on a dose of 300 mg daily (300 mg qd). In week 2, participants will take 300 mg of gabapentin three times daily. In week 3 the dose will be titrated up to 1800 mg daily (300 mg+300 mg tid) will remain on the dose until week 8, when they will be tapered back down to 900 mg daily (300 mg tid). In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
Gabapentin: Dose will begin at 300 mg daily (300 mg qd), in week 2 the dose will be titrated up to 900 mg daily (300 mg tid). In week 3, the dose will be titrated to 1800 mg daily ( 2 capsules of 300 mg tid) and participants will remain on that dose until week 8. In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
|
Placebo
n=15 Participants
Participants will receive a placebo to be taken three times daily for 8 weeks.
Placebo: In week 1, participants will take 1 placebo capsule once daily. In week 2, participants will take 1 placebo capsule three times per day. In weeks 3 through 7, 2 placebo capsules three times per day. In week 8, in days 1-4 participants will take 2 placebo capsules three times per day; in days 5-7, participants will take 1 placebo capsule three times per day. The placebo medications will be composed of lactose and will not contain active ingredients.
|
|---|---|---|---|
|
Change in IL-1beta
|
0.30 pg/ml
Standard Error 0.22
|
0.95 pg/ml
Standard Error 0.29
|
0.41 pg/ml
Standard Error 0.20
|
Adverse Events
Low-dose Naltrexone
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Gabapentin
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low-dose Naltrexone
n=15 participants at risk
Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.
Low-dose naltrexone: 4.5 mg of low dose naltrexone taken once daily for 8 weeks. In week 1, participants will take 4.5mg of naltrexone once daily. In week 2, participants will take 4.5mg of naltrexone once daily, and a placebo capsule twice daily. In weeks 3 through 7, participants will take 1 placebo capsule with 4.5 mg mg of naltrexone once daily, and 2 placebo capsules twice daily. In week 8, in days 1-4 participants will take 4.5 mg of naltrexone with a placebo capsule once daily and 2 placebo capsules twice daily; in days 5-7, participants will take 4.5 mg of naltrexone once daily, and a placebo capsule twice daily.
|
Gabapentin
n=15 participants at risk
Participants randomized to the gabapentin arm begin on a dose of 300 mg daily (300 mg qd). In week 2, participants will take 300 mg of gabapentin three times daily. In week 3 the dose will be titrated up to 1800 mg daily (300 mg+300 mg tid) will remain on the dose until week 8, when they will be tapered back down to 900 mg daily (300 mg tid). In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
Gabapentin: Dose will begin at 300 mg daily (300 mg qd), in week 2 the dose will be titrated up to 900 mg daily (300 mg tid). In week 3, the dose will be titrated to 1800 mg daily ( 2 capsules of 300 mg tid) and participants will remain on that dose until week 8. In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
|
Placebo
n=15 participants at risk
Participants will receive a placebo to be taken three times daily for 8 weeks.
Placebo: In week 1, participants will take 1 placebo capsule once daily. In week 2, participants will take 1 placebo capsule three times per day. In weeks 3 through 7, 2 placebo capsules three times per day. In week 8, in days 1-4 participants will take 2 placebo capsules three times per day; in days 5-7, participants will take 1 placebo capsule three times per day. The placebo medications will be composed of lactose and will not contain active ingredients.
|
|---|---|---|---|
|
Nervous system disorders
Seizure
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from baseline to 12 weeks.
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
|
Reproductive system and breast disorders
Surgery for Acute purulent non-lactation mastitis on the left side
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from baseline to 12 weeks.
|
Other adverse events
| Measure |
Low-dose Naltrexone
n=15 participants at risk
Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.
Low-dose naltrexone: 4.5 mg of low dose naltrexone taken once daily for 8 weeks. In week 1, participants will take 4.5mg of naltrexone once daily. In week 2, participants will take 4.5mg of naltrexone once daily, and a placebo capsule twice daily. In weeks 3 through 7, participants will take 1 placebo capsule with 4.5 mg mg of naltrexone once daily, and 2 placebo capsules twice daily. In week 8, in days 1-4 participants will take 4.5 mg of naltrexone with a placebo capsule once daily and 2 placebo capsules twice daily; in days 5-7, participants will take 4.5 mg of naltrexone once daily, and a placebo capsule twice daily.
|
Gabapentin
n=15 participants at risk
Participants randomized to the gabapentin arm begin on a dose of 300 mg daily (300 mg qd). In week 2, participants will take 300 mg of gabapentin three times daily. In week 3 the dose will be titrated up to 1800 mg daily (300 mg+300 mg tid) will remain on the dose until week 8, when they will be tapered back down to 900 mg daily (300 mg tid). In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
Gabapentin: Dose will begin at 300 mg daily (300 mg qd), in week 2 the dose will be titrated up to 900 mg daily (300 mg tid). In week 3, the dose will be titrated to 1800 mg daily ( 2 capsules of 300 mg tid) and participants will remain on that dose until week 8. In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
|
Placebo
n=15 participants at risk
Participants will receive a placebo to be taken three times daily for 8 weeks.
Placebo: In week 1, participants will take 1 placebo capsule once daily. In week 2, participants will take 1 placebo capsule three times per day. In weeks 3 through 7, 2 placebo capsules three times per day. In week 8, in days 1-4 participants will take 2 placebo capsules three times per day; in days 5-7, participants will take 1 placebo capsule three times per day. The placebo medications will be composed of lactose and will not contain active ingredients.
|
|---|---|---|---|
|
Cardiac disorders
Hypertension
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from baseline to 12 weeks.
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
|
General disorders
Fatigue
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected from baseline to 12 weeks.
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from baseline to 12 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from baseline to 12 weeks.
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
|
Gastrointestinal disorders
Stomach pain
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from baseline to 12 weeks.
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
|
Gastrointestinal disorders
Loss of appetite
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from baseline to 12 weeks.
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from baseline to 12 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from baseline to 12 weeks.
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from baseline to 12 weeks.
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from baseline to 12 weeks.
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
|
Nervous system disorders
Speech impediment
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from baseline to 12 weeks.
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
|
Nervous system disorders
Tremor
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from baseline to 12 weeks.
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
|
Nervous system disorders
Confusion
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from baseline to 12 weeks.
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
|
Psychiatric disorders
Sleepiness
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from baseline to 12 weeks.
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
|
Psychiatric disorders
Insomnia
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from baseline to 12 weeks.
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from baseline to 12 weeks.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from baseline to 12 weeks.
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
|
Infections and infestations
Cold
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from baseline to 12 weeks.
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Burning in the legs
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from baseline to 12 weeks.
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Redness of the skin of the upper body
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
0.00%
0/15 • Adverse event data were collected from baseline to 12 weeks.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from baseline to 12 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place