Trial Outcomes & Findings for St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Nalmefene (NCT NCT03278886)
NCT ID: NCT03278886
Last Updated: 2020-08-24
Results Overview
Medication tolerability will be measured via a 0-100 visual analog scale. Participants will be asked to indicate on a scale of 0-100, how well they have tolerated the study medication with 0 anchored as "cannot tolerate at all" and 100 as "tolerate perfectly well." Higher numbers will be indicative of higher tolerability of the medication.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
11 participants
Primary outcome timeframe
Primary endpoint at 8 weeks
Results posted on
2020-08-24
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
|
Nalmefene
Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.
Nalmefene: 18 mg of nalmefene taken once daily for 8 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
3
|
|
Overall Study
COMPLETED
|
8
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Low Dose Naltrexone
n=8 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
|
Nalmefene
n=3 Participants
Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.
Nalmefene: 18 mg of nalmefene taken once daily for 8 weeks
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.3 years
STANDARD_DEVIATION 7.46 • n=8 Participants
|
35.7 years
STANDARD_DEVIATION 1.09 • n=3 Participants
|
37.8 years
STANDARD_DEVIATION 7.02 • n=11 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=8 Participants
|
1 Participants
n=3 Participants
|
6 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=8 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=11 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Russia
|
8 Participants
n=8 Participants
|
3 Participants
n=3 Participants
|
11 Participants
n=11 Participants
|
|
Education (9 grades or more)
|
8 Participants
n=8 Participants
|
3 Participants
n=3 Participants
|
11 Participants
n=11 Participants
|
|
Married/Living with partner/In long-term relationship
|
5 Participants
n=8 Participants
|
3 Participants
n=3 Participants
|
8 Participants
n=11 Participants
|
|
At risk drinking based on NIAAA criteria
|
2 Participants
n=8 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=11 Participants
|
|
Lifetime opioid use
|
5 Participants
n=8 Participants
|
3 Participants
n=3 Participants
|
8 Participants
n=11 Participants
|
|
Past 30 day opioid use
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=11 Participants
|
|
Pain severity
|
3.0 units on a scale
n=8 Participants
|
4.5 units on a scale
n=3 Participants
|
3.3 units on a scale
n=11 Participants
|
|
Pain interference
|
2.5 units on a scale
n=8 Participants
|
5.6 units on a scale
n=3 Participants
|
4.1 units on a scale
n=11 Participants
|
|
Cold pain threshold
|
9.5 seconds
n=8 Participants
|
10 seconds
n=3 Participants
|
10 seconds
n=11 Participants
|
|
Cold pain tolerance
|
19.3 seconds
n=8 Participants
|
22 seconds
n=3 Participants
|
19.5 seconds
n=11 Participants
|
PRIMARY outcome
Timeframe: Primary endpoint at 8 weeksMedication tolerability will be measured via a 0-100 visual analog scale. Participants will be asked to indicate on a scale of 0-100, how well they have tolerated the study medication with 0 anchored as "cannot tolerate at all" and 100 as "tolerate perfectly well." Higher numbers will be indicative of higher tolerability of the medication.
Outcome measures
| Measure |
Low Dose Naltrexone
n=8 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
|
Nalmefene
n=2 Participants
Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.
Nalmefene: 18 mg of nalmefene taken once daily for 8 weeks
|
|---|---|---|
|
Medication Tolerability Measured Via a 0-100 Visual Analog Scale
|
90.7 score on a scale
Standard Deviation 22.4
|
NA score on a scale
Standard Deviation NA
All participants randomized to this arm discontinued study medication due to side effects. At 8-weeks, no participants in this arm were taking the study medication, so a tolerability score was not assessed.
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksMeasured via 30 Day Alcohol Use Timeline Follow Back Method
Outcome measures
| Measure |
Low Dose Naltrexone
n=8 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
|
Nalmefene
n=2 Participants
Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.
Nalmefene: 18 mg of nalmefene taken once daily for 8 weeks
|
|---|---|---|
|
Change in Alcohol Use Defined as a Change in the Mean Number of Grams of Pure Ethanol Consumed Per Day From Baseline to 8 Weeks
|
5.5 grams of ethanol
Standard Deviation 10.1
|
-6.83 grams of ethanol
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: 4 weeks, 8 weeksMeasured via one question asking participants if they had discontinued medication since their last visit. Assessed at 4 and 8 week study visits.
Outcome measures
| Measure |
Low Dose Naltrexone
n=8 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
|
Nalmefene
n=2 Participants
Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.
Nalmefene: 18 mg of nalmefene taken once daily for 8 weeks
|
|---|---|---|
|
Treatment Discontinuation Defined as Patient Self-report of Stopping Medication Anytime During the Treatment Period
4-Weeks
|
1 treatment discontinuations
|
1 treatment discontinuations
|
|
Treatment Discontinuation Defined as Patient Self-report of Stopping Medication Anytime During the Treatment Period
8-Weeks
|
1 treatment discontinuations
|
2 treatment discontinuations
|
SECONDARY outcome
Timeframe: Endpoint at 8 weeksMeasured by participants' drawing a line on a a Visual Analog Scale, which ranges from 0 to 100. Higher numbers indicate higher adherence to study medication.
Outcome measures
| Measure |
Low Dose Naltrexone
n=8 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
|
Nalmefene
n=2 Participants
Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.
Nalmefene: 18 mg of nalmefene taken once daily for 8 weeks
|
|---|---|---|
|
Adherence to Medication Defined as Self-report of Percentage of Study Medication Taken in the Past Two Weeks
|
87.5 score on a scale
Standard Deviation 35.4
|
0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Endpoint at 8 weeksMeasured through visual inspection of the urine for the presence or absence of riboflavin using ultraviolet (UV) light at the long wave setting (33 mm) in a room with low ambient light.
Outcome measures
| Measure |
Low Dose Naltrexone
n=8 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
|
Nalmefene
n=2 Participants
Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.
Nalmefene: 18 mg of nalmefene taken once daily for 8 weeks
|
|---|---|---|
|
Number of Participants With Adherence Assessed Via Riboflavin in the Urine Confirming Adherence
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 2 weeks, 4 weeks, 6 weeks, 8 weeksMeasured via a 16-item symptom checklist with the option for participants to report any experienced side effects not on the checklist. Side effect severity is rated by trained research assessors. The checklist is asked at 2, 4, 6, and 8-week study visits.
Outcome measures
| Measure |
Low Dose Naltrexone
n=8 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
|
Nalmefene
n=2 Participants
Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.
Nalmefene: 18 mg of nalmefene taken once daily for 8 weeks
|
|---|---|---|
|
Reported Side Effects Using a Symptom Checklist, Plus an Open-ended Question
2-Weeks
|
1.5 number of side effects
Standard Deviation 1.6
|
4.5 number of side effects
Standard Deviation 6.4
|
|
Reported Side Effects Using a Symptom Checklist, Plus an Open-ended Question
4-Weeks
|
1.3 number of side effects
Standard Deviation 1.2
|
1.5 number of side effects
Standard Deviation 2.1
|
|
Reported Side Effects Using a Symptom Checklist, Plus an Open-ended Question
6-Weeks
|
0.9 number of side effects
Standard Deviation 1.0
|
1.5 number of side effects
Standard Deviation 2.1
|
|
Reported Side Effects Using a Symptom Checklist, Plus an Open-ended Question
8-Weeks
|
0 number of side effects
Standard Deviation 0
|
0 number of side effects
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 4 weeks, 8 weeksMeasured via using the 14-item Treatment Satisfaction Questionnaire, which consists of 14 items that result in four domains: Effectiveness, Side Effects, Convenience and Global Satisfaction. Higher scores indicate greater satisfaction with medication. Assessed at 4 and 8 week study visits.
Outcome measures
| Measure |
Low Dose Naltrexone
n=8 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
|
Nalmefene
n=2 Participants
Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.
Nalmefene: 18 mg of nalmefene taken once daily for 8 weeks
|
|---|---|---|
|
Medication Satisfaction Defined as a Score From 0-100 Measured Via the Treatment Satisfaction Questionnaire for Medication (TSQM), With Higher Scores Corresponding to Higher Treatment Satisfaction.
4-Weeks
|
47.3 score on a scale
Standard Deviation 24.4
|
3.6 score on a scale
Standard Deviation 5.1
|
|
Medication Satisfaction Defined as a Score From 0-100 Measured Via the Treatment Satisfaction Questionnaire for Medication (TSQM), With Higher Scores Corresponding to Higher Treatment Satisfaction.
8-Weeks
|
47.3 score on a scale
Standard Deviation 21.9
|
3.6 score on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: Endpoint at 8 weeksAminotransferase levels (AST/ALT) are tested to look for severe hepatotoxicity defined as AST/ALT \> 10 times the level of normal.
Outcome measures
| Measure |
Low Dose Naltrexone
n=8 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
|
Nalmefene
n=2 Participants
Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.
Nalmefene: 18 mg of nalmefene taken once daily for 8 weeks
|
|---|---|---|
|
Severe Hepatotoxicity Defined as AST/ALT >10X the Level of Normal
|
0 participants
|
0 participants
|
Adverse Events
Low Dose Naltrexone
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Nalmefene
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low Dose Naltrexone
n=8 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
|
Nalmefene
n=3 participants at risk
Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.
Nalmefene: 18 mg of nalmefene taken once daily for 8 weeks
|
|---|---|---|
|
Injury, poisoning and procedural complications
Body injury during fight
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected over the course of the 8-week treatment period.
|
0.00%
0/3 • Adverse event data were collected over the course of the 8-week treatment period.
|
Other adverse events
| Measure |
Low Dose Naltrexone
n=8 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
|
Nalmefene
n=3 participants at risk
Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.
Nalmefene: 18 mg of nalmefene taken once daily for 8 weeks
|
|---|---|---|
|
General disorders
Agitation
|
0.00%
0/8 • Adverse event data were collected over the course of the 8-week treatment period.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected over the course of the 8-week treatment period.
|
|
General disorders
Irritability
|
0.00%
0/8 • Adverse event data were collected over the course of the 8-week treatment period.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected over the course of the 8-week treatment period.
|
|
General disorders
Weakness
|
0.00%
0/8 • Adverse event data were collected over the course of the 8-week treatment period.
|
66.7%
2/3 • Number of events 2 • Adverse event data were collected over the course of the 8-week treatment period.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Adverse event data were collected over the course of the 8-week treatment period.
|
66.7%
2/3 • Number of events 2 • Adverse event data were collected over the course of the 8-week treatment period.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Adverse event data were collected over the course of the 8-week treatment period.
|
66.7%
2/3 • Number of events 2 • Adverse event data were collected over the course of the 8-week treatment period.
|
|
Nervous system disorders
Tremor
|
0.00%
0/8 • Adverse event data were collected over the course of the 8-week treatment period.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected over the course of the 8-week treatment period.
|
|
Psychiatric disorders
Abnormal dreams/nightmares
|
0.00%
0/8 • Adverse event data were collected over the course of the 8-week treatment period.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected over the course of the 8-week treatment period.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • Adverse event data were collected over the course of the 8-week treatment period.
|
66.7%
2/3 • Number of events 2 • Adverse event data were collected over the course of the 8-week treatment period.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/8 • Adverse event data were collected over the course of the 8-week treatment period.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected over the course of the 8-week treatment period.
|
|
Psychiatric disorders
Sleep problems
|
0.00%
0/8 • Adverse event data were collected over the course of the 8-week treatment period.
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected over the course of the 8-week treatment period.
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected over the course of the 8-week treatment period.
|
0.00%
0/3 • Adverse event data were collected over the course of the 8-week treatment period.
|
|
Gastrointestinal disorders
Loss of appetite
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected over the course of the 8-week treatment period.
|
0.00%
0/3 • Adverse event data were collected over the course of the 8-week treatment period.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected over the course of the 8-week treatment period.
|
0.00%
0/3 • Adverse event data were collected over the course of the 8-week treatment period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place