Trial Outcomes & Findings for Effects of Low Dose Naltrexone in Fibromyalgia (NCT NCT00568555)
NCT ID: NCT00568555
Last Updated: 2015-10-21
Results Overview
Visual Analogue Scale for pain, 0 to 100, where 0=no pain and 100=worst pain imaginable. Baseline pain calculated averaging daily pain scores over the 2 week baseline period. Placebo and LDN pain scores calculated by averaging daily pain scores during the final 3 days of each condition. Values were converted to percent change in pain: \[(baseline pain - end point pain)/baseline pain\] x 100.
COMPLETED
NA
53 participants
Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)
2015-10-21
Participant Flow
325 women completed an online web survey
Individuals were assessed for eligibility via web screening and phone screening prior to enrollment. Further eligibility (blood tests, questionnaires) assessed after enrollment; ineligible consented participants were withdrawn prior to assignment to groups.
Participant milestones
| Measure |
Low Dose Naltrexone First
Low Dose Naltrexone (LDN) followed by placebo. LDN at 3-4.5mg, once a day. Placebo (sugar pill) once a day.
|
Placebo - Sugar Pill First
Placebo first, followed by LDN. Placebo (sugar pill) once a day. LDN at 3-4.5mg, once a day.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
COMPLETED
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Low Dose Naltrexone First
Low Dose Naltrexone (LDN) followed by placebo. LDN at 3-4.5mg, once a day. Placebo (sugar pill) once a day.
|
Placebo - Sugar Pill First
Placebo first, followed by LDN. Placebo (sugar pill) once a day. LDN at 3-4.5mg, once a day.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Effects of Low Dose Naltrexone in Fibromyalgia
Baseline characteristics by cohort
| Measure |
Low Dose Naltrexone
n=14 Participants
|
Placebo - Sugar Pill
n=14 Participants
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
43.8 years
STANDARD_DEVIATION 13.4 • n=93 Participants
|
42.3 years
STANDARD_DEVIATION 13.0 • n=4 Participants
|
42.7 years
STANDARD_DEVIATION 12.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=93 Participants
|
14 participants
n=4 Participants
|
28 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)Population: All completers
Visual Analogue Scale for pain, 0 to 100, where 0=no pain and 100=worst pain imaginable. Baseline pain calculated averaging daily pain scores over the 2 week baseline period. Placebo and LDN pain scores calculated by averaging daily pain scores during the final 3 days of each condition. Values were converted to percent change in pain: \[(baseline pain - end point pain)/baseline pain\] x 100.
Outcome measures
| Measure |
Low Dose Naltrexone
n=28 Participants
All participants during the Low Dose Naltrexone condition
|
Placebo - Sugar Pill
n=28 Participants
All participants during the placebo condition
|
|---|---|---|
|
Percent Change in Pain Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.
|
28.8 percentage change from baseline to final
Interval 19.5 to 38.1
|
18.0 percentage change from baseline to final
Interval 7.2 to 28.8
|
SECONDARY outcome
Timeframe: Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)Population: All completers
Visual Analogue Scale for sleep quality, 0 to 100, where 0 = "did not sleep well at all" and 100 = "slept extremely well". Baseline sleep quality calculated by averaging daily scores over the 2 week baseline period. Placebo and LDN sleep quality scores calculated by averaging daily scores during the final 3 days of each condition. Values were converted to percent change in sleep quality: \[(baseline sleep - end point sleep)/baseline sleep\] x 100.
Outcome measures
| Measure |
Low Dose Naltrexone
n=28 Participants
All participants during the Low Dose Naltrexone condition
|
Placebo - Sugar Pill
n=28 Participants
All participants during the placebo condition
|
|---|---|---|
|
Percent Change in Sleep Quality Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.
|
10.4 percentage change from baseline
Interval -35.8 to 56.6
|
9.2 percentage change from baseline
Interval -40.6 to 59.0
|
SECONDARY outcome
Timeframe: Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)Population: All completers
Visual Analogue Scale for fatigue, 0 to 100, where 0 = "no fatigue at all" and 100 = "severe fatigue". Baseline fatigue calculated averaging daily scores over the 2 week baseline period. Placebo and LDN fatigue scores calculated by averaging daily scores during the final 3 days of each condition. Values were converted to percent change in fatigue: \[(baseline fatigue - end point fatigue)/baseline fatigue\] x 100.
Outcome measures
| Measure |
Low Dose Naltrexone
n=28 Participants
All participants during the Low Dose Naltrexone condition
|
Placebo - Sugar Pill
n=28 Participants
All participants during the placebo condition
|
|---|---|---|
|
Percent Change in Fatigue Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.
|
12.6 percentage change from baseline
Interval -33.2 to 58.4
|
7.8 percentage change from baseline
Interval -26.6 to 42.2
|
SECONDARY outcome
Timeframe: Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)Population: All completers
An algometer is used to apply pressure to 18 points across the body. Pressure is applied until the first sensation of pain in indicated. This pressure is recorded (as kg/cm2) and averaged for all 18 points to provide an overall score.
Outcome measures
| Measure |
Low Dose Naltrexone
n=28 Participants
All participants during the Low Dose Naltrexone condition
|
Placebo - Sugar Pill
n=28 Participants
All participants during the placebo condition
|
|---|---|---|
|
Percent Change in Pressure Pain Threshold Between Baseline and End of Placebo Treatment and Between Baseline to End of LDN Treatment.
|
36.70 percentage change from baseline to final
Interval 17.41 to 56.0
|
28.26 percentage change from baseline to final
Interval 11.27 to 45.24
|
SECONDARY outcome
Timeframe: Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)Population: All completers
A thermode is placed on the palm, and temperature is increased until the first sensation of pain. That temperature is recorded in Degrees Celsius . The procedure is repeated 3 times and results are averaged into a single temperature recording.
Outcome measures
| Measure |
Low Dose Naltrexone
n=28 Participants
All participants during the Low Dose Naltrexone condition
|
Placebo - Sugar Pill
n=28 Participants
All participants during the placebo condition
|
|---|---|---|
|
Percent Change in Heat Pain Sensitivity Between Baseline and End of Placebo Treatment and Between Baseline to End of LDN Treatment.
|
3.12 percentage change from baseline to final
Interval 0.4 to 5.83
|
3.45 percentage change from baseline to final
Interval 0.93 to 5.98
|
Adverse Events
Low Dose Naltrexone
Placebo - Sugar Pill
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Dose Naltrexone
n=28 participants at risk
All participants during the Low Dose Naltrexone condition
|
Placebo - Sugar Pill
n=28 participants at risk
All participants during the placebo condition
|
|---|---|---|
|
General disorders
Vivid Dreams
|
35.7%
10/28
|
14.3%
4/28
|
|
General disorders
Headache
|
14.3%
4/28
|
3.6%
1/28
|
|
General disorders
Nausea/Upset Stomach
|
14.3%
4/28
|
7.1%
2/28
|
|
General disorders
Nightmares
|
10.7%
3/28
|
3.6%
1/28
|
|
General disorders
Insomnia
|
14.3%
4/28
|
10.7%
3/28
|
|
General disorders
Dry mouth or throat
|
10.7%
3/28
|
3.6%
1/28
|
Additional Information
Jarred Younger, PhD
Stanford University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place