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St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Nalmefene (PETER PAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03278886
Recruitment Status : Completed
First Posted : September 12, 2017
Results First Posted : August 3, 2020
Last Update Posted : August 3, 2020
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Jeffrey Samet, Boston Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions HIV Infection
Alcohol Use
Pain
Interventions Drug: Low dose naltrexone
Drug: Nalmefene
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Low Dose Naltrexone Nalmefene
Hide Arm/Group Description

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

Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.

Nalmefene: 18 mg of nalmefene taken once daily for 8 weeks

Period Title: Overall Study
Started 8 3
Completed 8 2
Not Completed 0 1
Arm/Group Title Low Dose Naltrexone Nalmefene Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 8 3 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 3 participants 11 participants
38.3  (7.46) 35.7  (1.09) 37.8  (7.02)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 3 participants 11 participants
Female
5
  62.5%
1
  33.3%
6
  54.5%
Male
3
  37.5%
2
  66.7%
5
  45.5%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Russia Number Analyzed 8 participants 3 participants 11 participants
8
 100.0%
3
 100.0%
11
 100.0%
Education (9 grades or more)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 3 participants 11 participants
8
 100.0%
3
 100.0%
11
 100.0%
Married/Living with partner/In long-term relationship  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 3 participants 11 participants
5
  62.5%
3
 100.0%
8
  72.7%
At risk drinking based on NIAAA criteria  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 3 participants 11 participants
2
  25.0%
1
  33.3%
3
  27.3%
Lifetime opioid use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 3 participants 11 participants
5
  62.5%
3
 100.0%
8
  72.7%
Past 30 day opioid use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 3 participants 11 participants
0
   0.0%
0
   0.0%
0
   0.0%
Pain severity   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 8 participants 3 participants 11 participants
3.0
(2.1 to 4.5)
4.5
(4.0 to 5.5)
3.3
(2.5 to 5.5)
[1]
Measure Description: Scale of 1-10 with higher numbers indicating greater levels of pain
Pain interference   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 8 participants 3 participants 11 participants
2.5
(2.0 to 6.7)
5.6
(4.1 to 7.9)
4.1
(2.1 to 6.1)
[1]
Measure Description: Scale of 1-10 with higher numbers indicating greater levels of pain
Cold pain threshold  
Median (Inter-Quartile Range)
Unit of measure:  Seconds
Number Analyzed 8 participants 3 participants 11 participants
9.5
(7.9 to 13.5)
10
(3.6 to 13.5)
10
(6.7 to 13.1)
Cold pain tolerance  
Median (Inter-Quartile Range)
Unit of measure:  Seconds
Number Analyzed 8 participants 3 participants 11 participants
19.3
(16.5 to 22.8)
22
(8.2 to 22.5)
19.5
(14 to 22.5)
1.Primary Outcome
Title Medication Tolerability Measured Via a 0-100 Visual Analog Scale
Hide Description 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.
Time Frame Primary endpoint at 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Naltrexone Nalmefene
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 8 2
Mean (Standard Deviation)
Unit of Measure: score on a scale
90.7  (22.4) NA [1]   (NA)
[1]
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.
2.Secondary Outcome
Title Alcohol Reduction Defined as a Decrease in Mean Number of Grams of Pure Ethanol Consumed Per Day From Baseline to 8 Weeks
Hide Description Measured via 30 Day Alcohol Use Timeline Follow Back Method
Time Frame Endpoint at 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Naltrexone Nalmefene
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 8 2
Mean (Standard Deviation)
Unit of Measure: grams of ethanol
-5.5  (10.1) 6.83  (9.7)
3.Secondary Outcome
Title Treatment Discontinuation Defined as Patient Self-report of Stopping Medication Anytime During the Treatment Period
Hide Description Measured via one question asking participants if they had discontinued medication since their last visit. Assessed at 4 and 8 week study visits.
Time Frame Endpoint at 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Naltrexone Nalmefene
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 8 2
Measure Type: Number
Unit of Measure: treatment discontinuations
4-Weeks 1 1
8-Weeks 1 2
4.Secondary Outcome
Title Adherence to Medication Defined as Self-report of Percentage of Study Medication Taken in the Past Two Weeks
Hide Description Measured 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.
Time Frame Endpoint at 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Naltrexone Nalmefene
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 8 2
Mean (Standard Deviation)
Unit of Measure: score on a scale
87.5  (35.4) 0  (0)
5.Secondary Outcome
Title Adherence Assessed Via Riboflavin in the Urine
Hide Description Measured 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.
Time Frame Endpoint at 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Naltrexone Nalmefene
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 8 2
Measure Type: Number
Unit of Measure: participants
1 0
6.Secondary Outcome
Title Reported Side Effects Using a Symptom Checklist, Plus an Open-ended Question
Hide Description Measured 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.
Time Frame Endpoint at 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Naltrexone Nalmefene
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 8 2
Mean (Standard Deviation)
Unit of Measure: number of side effects
2-Weeks 1.5  (1.6) 4.5  (6.4)
4-Weeks 1.3  (1.2) 1.5  (2.1)
6-Weeks 0.9  (1.0) 1.5  (2.1)
8-Weeks 0  (0) 0  (0)
7.Secondary Outcome
Title 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.
Hide Description Measured 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. Assessed at 4 and 8 week study visits.
Time Frame Endpoint at 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Naltrexone Nalmefene
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 8 2
Mean (Standard Deviation)
Unit of Measure: score on a scale
4-Weeks 47.3  (24.4) 3.6  (5.1)
8-Weeks 47.3  (21.9) 3.6  (5.1)
8.Secondary Outcome
Title Severe Hepatotoxicity Defined as AST/ALT >10X the Level of Normal
Hide Description Aminotransferase levels (AST/ALT) are tested at 4 and 8 weeks to look for severe hepatotoxicity defined as AST/ALT > 10 times the level of normal.
Time Frame Endpoint at 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Naltrexone Nalmefene
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 8 2
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame Adverse event data were collected over the course of the 8-week treatment period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low Dose Naltrexone Nalmefene
Hide Arm/Group Description

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

Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.

Nalmefene: 18 mg of nalmefene taken once daily for 8 weeks

All-Cause Mortality
Low Dose Naltrexone Nalmefene
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)      0/3 (0.00%)    
Hide Serious Adverse Events
Low Dose Naltrexone Nalmefene
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/8 (12.50%)      0/3 (0.00%)    
Injury, poisoning and procedural complications     
Body injury during fight  1  1/8 (12.50%)  1 0/3 (0.00%)  0
1
Term from vocabulary, CTCAE (5.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Low Dose Naltrexone Nalmefene
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/8 (37.50%)      3/3 (100.00%)    
Gastrointestinal disorders     
Nausea  1  0/8 (0.00%)  0 2/3 (66.67%)  2
Dry mouth  1  1/8 (12.50%)  1 0/3 (0.00%)  0
Loss of appetite  1  1/8 (12.50%)  1 0/3 (0.00%)  0
General disorders     
Agitation  1  0/8 (0.00%)  0 1/3 (33.33%)  1
Irritability  1  0/8 (0.00%)  0 1/3 (33.33%)  1
Weakness  1  0/8 (0.00%)  0 2/3 (66.67%)  2
Musculoskeletal and connective tissue disorders     
Neck pain  1  1/8 (12.50%)  1 0/3 (0.00%)  0
Nervous system disorders     
Dizziness  1  0/8 (0.00%)  0 2/3 (66.67%)  2
Tremor  1  0/8 (0.00%)  0 1/3 (33.33%)  1
Psychiatric disorders     
Abnormal dreams/nightmares  1  0/8 (0.00%)  0 1/3 (33.33%)  1
Anxiety  1  0/8 (0.00%)  0 2/3 (66.67%)  2
Confusion  1  0/8 (0.00%)  0 1/3 (33.33%)  1
Sleep problems  1  0/8 (0.00%)  0 1/3 (33.33%)  1
1
Term from vocabulary, CTCAE (5.0)
Indicates events were collected by systematic assessment
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. Jeffrey Samet
Organization: Boston Medical Center
Phone: 617-414-7444
EMail: jsamet@bu.edu
Layout table for additonal information
Responsible Party: Jeffrey Samet, Boston Medical Center
ClinicalTrials.gov Identifier: NCT03278886    
Other Study ID Numbers: H-36491
UH2AA026193 ( U.S. NIH Grant/Contract )
First Submitted: September 5, 2017
First Posted: September 12, 2017
Results First Submitted: July 17, 2020
Results First Posted: August 3, 2020
Last Update Posted: August 3, 2020