Trial Outcomes & Findings for Kappa-PET Imaging and Naltrexone in Alcohol Drinking Behaviors (NCT NCT01625611)
NCT ID: NCT01625611
Last Updated: 2022-08-10
Results Overview
To determine the degree to which occupancy of KORs by a 100 mg/day dose of NTX mediates (influences the strength of) responsivity to NTX treatment in all heavy drinkers.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
59 participants
Primary outcome timeframe
6-8 days after treatment with naltrexone
Results posted on
2022-08-10
Participant Flow
Participants were recruited from the community through various methods such as flyers and online.
All enrolled participants were assigned to a study arm.
Participant milestones
| Measure |
Naltrexone
Naltrexone: Naltrexone 100 mg titrated over one week
|
Healthy Controls
No treatment, baseline measurements only.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
4
|
|
Overall Study
PET Scan 1
|
49
|
4
|
|
Overall Study
Lab 2
|
48
|
0
|
|
Overall Study
PET Scan 2
|
47
|
0
|
|
Overall Study
COMPLETED
|
47
|
4
|
|
Overall Study
NOT COMPLETED
|
8
|
0
|
Reasons for withdrawal
| Measure |
Naltrexone
Naltrexone: Naltrexone 100 mg titrated over one week
|
Healthy Controls
No treatment, baseline measurements only.
|
|---|---|---|
|
Overall Study
No adlib drinks Lab 1
|
3
|
0
|
|
Overall Study
Technical issues with PET
|
1
|
0
|
|
Overall Study
Unable to complete study procedures
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
Kappa-PET Imaging and Naltrexone in Alcohol Drinking Behaviors
Baseline characteristics by cohort
| Measure |
Naltrexone
n=47 Participants
Naltrexone: Naltrexone 100 mg titrated over one week
|
Healthy Controls
n=4 Participants
No treatment, baseline measurements only.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32 years
STANDARD_DEVIATION 3.9 • n=39 Participants
|
35.6 years
STANDARD_DEVIATION 11.4 • n=41 Participants
|
33.8 years
STANDARD_DEVIATION 7.7 • n=35 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
32 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
43 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
28 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=39 Participants
|
4 participants
n=41 Participants
|
51 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 6-8 days after treatment with naltrexoneTo determine the degree to which occupancy of KORs by a 100 mg/day dose of NTX mediates (influences the strength of) responsivity to NTX treatment in all heavy drinkers.
Outcome measures
| Measure |
Naltrexone
n=44 Participants
Naltrexone: Naltrexone 100 mg titrated over one week
|
Naltrexone - FH Negative
Naltrexone: Naltrexone 100 mg titrated over one week
|
|---|---|---|
|
Occupancy of KOR by NTX and Drinking
|
92 % Occupancy
Standard Error 1
|
—
|
PRIMARY outcome
Timeframe: 6-8 days after treatment with naltrexoneTo determine whether the relationship between NTX responsivity and occupancy of KOR is different in family history positive vs. family history negative heavy drinkers. Evaluations were done with a logistic regression which included years of drinking (a covariate), family history status, and occupancy of KOR. The logistic model calculated a probability of response, defined as a 50% or greater reduction in drinking after naltrexone, for every participant. Reported outcome is the area under the ROC produced by the model. The closer the value is to 100 percent probability, the better the model is at correctly classifying the observations.
Outcome measures
| Measure |
Naltrexone
n=44 Participants
Naltrexone: Naltrexone 100 mg titrated over one week
|
Naltrexone - FH Negative
Naltrexone: Naltrexone 100 mg titrated over one week
|
|---|---|---|
|
Relationship Between NTX Responsivity and Occupancy of KOR
|
84 percent probability
|
—
|
SECONDARY outcome
Timeframe: at baseline prior to treatment with naltrexoneTo determine if baseline levels of KOR differ between family history positive (FHP) and family history negative (FHN) heavy drinkers and to determine if baseline KOR level is related to either baseline drinking or responsivity to NTX.
Outcome measures
| Measure |
Naltrexone
n=29 Participants
Naltrexone: Naltrexone 100 mg titrated over one week
|
Naltrexone - FH Negative
n=18 Participants
Naltrexone: Naltrexone 100 mg titrated over one week
|
|---|---|---|
|
Baseline KOR Differences
|
91.2 % Occupancy
Standard Error 1.7
|
94.2 % Occupancy
Standard Error 1.9
|
Adverse Events
Naltrexone
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Naltrexone
n=55 participants at risk
Naltrexone: Naltrexone 100 mg titrated over one week
|
Healthy Controls
n=4 participants at risk
No treatment, baseline measurements only.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
34.5%
19/55 • Number of events 22 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
Gastrointestinal disorders
Vomiting
|
10.9%
6/55 • Number of events 7 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
10.9%
6/55 • Number of events 7 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.5%
3/55 • Number of events 3 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
Nervous system disorders
Headache
|
16.4%
9/55 • Number of events 10 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
General disorders
Fatigue
|
7.3%
4/55 • Number of events 4 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
Psychiatric disorders
Anxiety
|
5.5%
3/55 • Number of events 3 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
General disorders
Insomnia
|
1.8%
1/55 • Number of events 1 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
General disorders
Drowsiness
|
3.6%
2/55 • Number of events 3 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
Psychiatric disorders
Depression
|
1.8%
1/55 • Number of events 1 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
General disorders
Cloudy
|
1.8%
1/55 • Number of events 1 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
General disorders
Cold sweat
|
1.8%
1/55 • Number of events 1 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
1.8%
1/55 • Number of events 1 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
General disorders
Hypothermia
|
1.8%
1/55 • Number of events 1 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
Gastrointestinal disorders
Constipation
|
3.6%
2/55 • Number of events 2 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
General disorders
Decreased desired to drink
|
1.8%
1/55 • Number of events 1 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
Reproductive system and breast disorders
Decreased sex drive
|
5.5%
3/55 • Number of events 3 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
1.8%
1/55 • Number of events 1 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
General disorders
Feeling high
|
5.5%
3/55 • Number of events 3 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
General disorders
Feeling good
|
1.8%
1/55 • Number of events 2 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
Renal and urinary disorders
Frequent urination
|
5.5%
3/55 • Number of events 3 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
Psychiatric disorders
Irritability
|
1.8%
1/55 • Number of events 2 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
1.8%
1/55 • Number of events 1 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
Skin and subcutaneous tissue disorders
Peeling hands
|
1.8%
1/55 • Number of events 1 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
Nervous system disorders
Tremor
|
3.6%
2/55 • Number of events 2 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
Gastrointestinal disorders
Stomach ache
|
1.8%
1/55 • Number of events 1 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
General disorders
Tightness in chest
|
1.8%
1/55 • Number of events 1 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
General disorders
Tired
|
5.5%
3/55 • Number of events 3 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
Gastrointestinal disorders
Upset stomach
|
1.8%
1/55 • Number of events 2 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
|
Gastrointestinal disorders
Apetite change
|
9.1%
5/55 • Number of events 5 • Approximately 3 weeks
|
0.00%
0/4 • Approximately 3 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place