Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Omegas 3 and 6 on Alcohol Dependence

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: NCT01211769
Recruitment Status : Completed
First Posted : September 29, 2010
Results First Posted : September 29, 2010
Last Update Posted : September 29, 2010
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Associacao Fundo de Incentivo a Psicofarmcologia
Information provided by:
Federal University of São Paulo

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Alcohol Dependence
Interventions Drug: Naltrexone
Drug: PUFAs
Drug: Placebo
Drug: Naltrexone + Placebo
Enrollment 80
Recruitment Details 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.
Pre-assignment Details

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.

Arm/Group Title Placebo Naltrexone PUFAs Naltrexone + PUFAs
Hide Arm/Group Description

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 chlorhydrate 50 mg

Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.

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;

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

Period Title: Overall Study
Started 20 20 20 20
Participants/Group 20 20 20 20
Completed 11 10 12 9
Not Completed 9 10 8 11
Reason Not Completed
Lost to Follow-up             7             9             5             9
Physician Decision             2             0             2             1
Adverse Event             0             1             1             1
Arm/Group Title Placebo Naltrexone PUFAs Naltrexone + PUFAs Total
Hide Arm/Group Description

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 chlorhydrate 50 mg

Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.

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;

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 of all reporting groups
Overall Number of Baseline Participants 20 20 20 20 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
<=18 years
00
   0.0%
00
   0.0%
00
   0.0%
00
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
20
 100.0%
20
 100.0%
20
 100.0%
80
 100.0%
>=65 years
00
   0.0%
00
   0.0%
00
   0.0%
00
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
45.0  (3.94) 42.0  (6.44) 40.66  (6.74) 43.33  (4.84) 42.67  (5.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
20
 100.0%
20
 100.0%
20
 100.0%
20
 100.0%
80
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
20 20 20 20 80
1.Primary Outcome
Title "Drinking Days" in the Previous Month
Hide Description 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.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Naltrexone PUFAs Naltrexone + PUFAs
Hide Arm/Group Description:

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 chlorhydrate 50 mg

Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.

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;

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 Number of Participants Analyzed 20 20 20 20
Mean (Standard Deviation)
Unit of Measure: Days
Number of "Drinking Days" Baseline 19.54  (9.85) 15.18  (10.32) 17.75  (9.80) 22.11  (11.63)
Number of "Drinking Days" Final 4.72  (8.74) 5.66  (7.48) 11.08  (12.87) 11.12  (13.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Naltrexone, PUFAs, Naltrexone + PUFAs
Comments TIME COMPARISON
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Naltrexone, PUFAs, Naltrexone + PUFAs
Comments GROUP COMPARISON
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Variance (F)
Estimated Value 0.71
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Short Alcohol Dependence Data Questionnaire (SADD)
Hide Description The 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.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Naltrexone PUFAs Naltrexone + PUFAs
Hide Arm/Group Description:

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 chlorhydrate 50 mg

Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.

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;

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 Number of Participants Analyzed 20 20 20 20
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
SADD Baseline 34.90  (8.93) 33.81  (9.92) 31.91  (10.99) 29.33  (11.11)
SADD Final 7.81  (11.93) 11.36  (14.29) 7.81  (11.93) 9.16  (11.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Naltrexone, PUFAs, Naltrexone + PUFAs
Comments TIME COMPARISON
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Naltrexone, PUFAs, Naltrexone + PUFAs
Comments GROUP COMPARISON
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Variance (F)
Estimated Value 0.73
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Obsessive Compulsive Drinking Scale (OCDS)
Hide Description The 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.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Naltrexone PUFAs Naltrexone + PUFAs
Hide Arm/Group Description:

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 chlorhydrate 50 mg

Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.

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;

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 Number of Participants Analyzed 20 20 20 20
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
OCDS Baseline 45.36  (9.86) 42.45  (12.56) 36.5  (14.88) 37.55  (10.47)
OCDS Final 13.18  (14.98) 11.81  (15.09) 19.16  (20.93) 14.00  (13.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Naltrexone, PUFAs, Naltrexone + PUFAs
Comments TIME COMPARISON
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Naltrexone, PUFAs, Naltrexone + PUFAs
Comments GROUP COMPARISON
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Variance (F)
Estimated Value 1.08
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Naltrexone PUFAs Naltrexone + PUFAs
Hide Arm/Group Description

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 chlorhydrate 50 mg

Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil.

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;

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

All-Cause Mortality
Placebo Naltrexone PUFAs Naltrexone + PUFAs
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Naltrexone PUFAs Naltrexone + PUFAs
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Naltrexone PUFAs Naltrexone + PUFAs
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      1/20 (5.00%)      1/20 (5.00%)      1/20 (5.00%)    
Gastrointestinal disorders         
Flatulence   0/20 (0.00%)  0 1/20 (5.00%)  3 1/20 (5.00%)  4 1/20 (5.00%)  1
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: José Carlos Fernandes Galduróz
Organization: UNIFESP
Phone: 55 11 21490168
EMail: galduroz@psicobio.epm.br
Layout table for additonal information
Responsible Party: José Carlos Fernandes Galduróz, Adjuncto Professor of UNIFESP
ClinicalTrials.gov Identifier: NCT01211769     History of Changes
Other Study ID Numbers: 2006/01641-6
First Submitted: December 5, 2008
First Posted: September 29, 2010
Results First Submitted: December 5, 2008
Results First Posted: September 29, 2010
Last Update Posted: September 29, 2010