Trial Outcomes & Findings for Effects of Omegas 3 and 6 on Alcohol Dependence (NCT NCT01211769)
NCT ID: NCT01211769
Last Updated: 2010-09-29
Results Overview
The Alcohol Timeline Followback (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
80 participants
Primary outcome timeframe
3 months
Results posted on
2010-09-29
Participant Flow
We comprised the sample through advertisement in newspaper and referral from outpatient services specialized in alcohol dependence treatment. The requirement for their participation was that they were not following any other treatment during the study.
645 individuals contacted; 325 were excluded after answering the questionnaire by phone. Most of the remaining 320 patients did not meet the inclusion criteria. 80 patients participated in the study.
Participant milestones
| Measure |
Placebo
Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.
|
Naltrexone
Naltrexone chlorhydrate 50 mg
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.
|
PUFAs
Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;
|
Naltrexone + PUFAs
Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
Naltrexone chlorhydrate 50 mg
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
20
|
|
Overall Study
Participants/Group
|
20
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
11
|
10
|
12
|
9
|
|
Overall Study
NOT COMPLETED
|
9
|
10
|
8
|
11
|
Reasons for withdrawal
| Measure |
Placebo
Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.
|
Naltrexone
Naltrexone chlorhydrate 50 mg
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.
|
PUFAs
Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;
|
Naltrexone + PUFAs
Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
Naltrexone chlorhydrate 50 mg
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
9
|
5
|
9
|
|
Overall Study
Physician Decision
|
2
|
0
|
2
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
1
|
Baseline Characteristics
Effects of Omegas 3 and 6 on Alcohol Dependence
Baseline characteristics by cohort
| Measure |
Placebo
n=20 Participants
Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.
|
Naltrexone
n=20 Participants
Naltrexone chlorhydrate 50 mg
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.
|
PUFAs
n=20 Participants
Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;
|
Naltrexone + PUFAs
n=20 Participants
Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
Naltrexone chlorhydrate 50 mg
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
00 Participants
n=5 Participants
|
00 Participants
n=7 Participants
|
00 Participants
n=5 Participants
|
00 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
00 Participants
n=5 Participants
|
00 Participants
n=7 Participants
|
00 Participants
n=5 Participants
|
00 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age Continuous
|
45.0 years
STANDARD_DEVIATION 3.94 • n=5 Participants
|
42.0 years
STANDARD_DEVIATION 6.44 • n=7 Participants
|
40.66 years
STANDARD_DEVIATION 6.74 • n=5 Participants
|
43.33 years
STANDARD_DEVIATION 4.84 • n=4 Participants
|
42.67 years
STANDARD_DEVIATION 5.72 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Region of Enrollment
Brazil
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
20 participants
n=4 Participants
|
80 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 3 monthsThe Alcohol Timeline Followback (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date.
Outcome measures
| Measure |
Placebo
n=20 Participants
Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.
|
Naltrexone
n=20 Participants
Naltrexone chlorhydrate 50 mg
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.
|
PUFAs
n=20 Participants
Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;
|
Naltrexone + PUFAs
n=20 Participants
Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
Naltrexone chlorhydrate 50 mg
|
|---|---|---|---|---|
|
"Drinking Days" in the Previous Month
Number of "Drinking Days" Baseline
|
19.54 Days
Standard Deviation 9.85
|
15.18 Days
Standard Deviation 10.32
|
17.75 Days
Standard Deviation 9.80
|
22.11 Days
Standard Deviation 11.63
|
|
"Drinking Days" in the Previous Month
Number of "Drinking Days" Final
|
4.72 Days
Standard Deviation 8.74
|
5.66 Days
Standard Deviation 7.48
|
11.08 Days
Standard Deviation 12.87
|
11.12 Days
Standard Deviation 13.74
|
SECONDARY outcome
Timeframe: 3 monthsThe Short Alcohol Dependence Data is a self-completion questionnaire designed to evaluate the presence and the degree of severity of alcohol dependence and consists of 15 questions. The minimum and maximum scores possible are 0 and 45 points respectively. The range of 1-9 is considered as low dependence, 10-19 medium dependence and 20 or more high dependence.
Outcome measures
| Measure |
Placebo
n=20 Participants
Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.
|
Naltrexone
n=20 Participants
Naltrexone chlorhydrate 50 mg
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.
|
PUFAs
n=20 Participants
Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;
|
Naltrexone + PUFAs
n=20 Participants
Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
Naltrexone chlorhydrate 50 mg
|
|---|---|---|---|---|
|
Short Alcohol Dependence Data Questionnaire (SADD)
SADD Baseline
|
34.90 Units on a Scale
Standard Deviation 8.93
|
33.81 Units on a Scale
Standard Deviation 9.92
|
31.91 Units on a Scale
Standard Deviation 10.99
|
29.33 Units on a Scale
Standard Deviation 11.11
|
|
Short Alcohol Dependence Data Questionnaire (SADD)
SADD Final
|
7.81 Units on a Scale
Standard Deviation 11.93
|
11.36 Units on a Scale
Standard Deviation 14.29
|
7.81 Units on a Scale
Standard Deviation 11.93
|
9.16 Units on a Scale
Standard Deviation 11.16
|
SECONDARY outcome
Timeframe: 3 monthsThe Obsessive Compulsive Drinking Scale (OCDS) is consisted by 14 items rated 0 - 4. The minimum and maximum values possibly obtained in this scale are respectively 0 and 56, this last one, meaning the most craving possible experienced. It is a short and easy to administer scale (average of 5 minutes per self-rating), built to measure severity and improvement during alcoholism treatment trials.
Outcome measures
| Measure |
Placebo
n=20 Participants
Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.
|
Naltrexone
n=20 Participants
Naltrexone chlorhydrate 50 mg
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.
|
PUFAs
n=20 Participants
Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;
|
Naltrexone + PUFAs
n=20 Participants
Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
Naltrexone chlorhydrate 50 mg
|
|---|---|---|---|---|
|
Obsessive Compulsive Drinking Scale (OCDS)
OCDS Baseline
|
45.36 Units on a Scale
Standard Deviation 9.86
|
42.45 Units on a Scale
Standard Deviation 12.56
|
36.5 Units on a Scale
Standard Deviation 14.88
|
37.55 Units on a Scale
Standard Deviation 10.47
|
|
Obsessive Compulsive Drinking Scale (OCDS)
OCDS Final
|
13.18 Units on a Scale
Standard Deviation 14.98
|
11.81 Units on a Scale
Standard Deviation 15.09
|
19.16 Units on a Scale
Standard Deviation 20.93
|
14.00 Units on a Scale
Standard Deviation 13.70
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Naltrexone
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PUFAs
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Naltrexone + PUFAs
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=20 participants at risk
Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.
|
Naltrexone
n=20 participants at risk
Naltrexone chlorhydrate 50 mg
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.
|
PUFAs
n=20 participants at risk
Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;
|
Naltrexone + PUFAs
n=20 participants at risk
Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;
Naltrexone chlorhydrate 50 mg
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/20
|
5.0%
1/20 • Number of events 3
|
5.0%
1/20 • Number of events 4
|
5.0%
1/20 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place