Alcohol Dependence
Conditions
Keywords
PUFAs, Alcoholism, Treatment, Effectiveness
Brief summary
Context: The treatment of alcoholism is a challenge for psychiatrists and patients. Some studies have shown that alcohol alters the environment of the membranes, mainly by modifying their permeability through the lipid fraction. These lipids are known as essential fatty acids (EFA) because they are obtained only through the diet, as the human body is unable to synthesize them. Linolenic acid (LA), or omega 6, and alpha-linolenic acid (ALA), or omega 3, are polyunsaturated fatty acids (PUFAs). Finally, ethanol changes the absorption and metabolism of PUFAs, and it's supplementation may be helpful for alcohol dependence recovery. Objective: to assess the effectiveness of PUFAs supplementation in the treatment of alcohol dependent patients.
Interventions
DRUGPUFAs
Borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram and Fish oil 1 gram - rich in omega 3 PUFAs; associated to a pill with 50mg of talcum powder, identical to the pill of naltrexone.
DRUGNaltrexone
A pill of naltrexone chlorhydrate 50mg, associated to yellow liquid paraffin pills simulating borage seed and fish oil.
DRUGPlacebo
A pill with 50mg of talcum powder, identical to the pill of naltrexone; associated to PUFAs Placebo pills (yellow liquid paraffin identical to the pills of borage seed and fish oil).
DRUGNaltrexone + Placebo
A pill of naltrexone chlorhydrate 50mg, associated to Borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram and Fish oil 1 gram - rich in omega 3 PUFAs.
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
Associacao Fundo de Incentivo a Psicofarmcologia
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
30 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* severe alcohol dependence * no history of allergic processes, hepatic, cardiovascular, renal, pulmonary, endocrine or neurological pathologies, as well as no history of psychiatric disorders, dependences other than alcohol and/or tobacco, and blood test results outside the reference range
Exclusion criteria
* history of allergic processes, hepatic, cardiovascular, renal, pulmonary, endocrine or neurological pathologies * dependences other than alcohol and/or tobacco * psychiatric disorders * test laboratories results outside the reference range
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drinking Days in the Previous Month | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Alcohol Dependence Data Questionnaire (SADD) | 3 months | 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. |
| Obsessive Compulsive Drinking Scale (OCDS) | 3 months | 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. |
Countries
Brazil
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Naltrexone Naltrexone chlorhydrate 50 mg
Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil. | 20 |
| 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; | 20 |
| 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 | 20 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 1 | 1 |
| Overall Study | Lost to Follow-up | 7 | 9 | 5 | 9 |
| Overall Study | Physician Decision | 2 | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | Naltrexone | PUFAs | Placebo | Naltrexone + PUFAs | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 00 Participants | 00 Participants | 00 Participants | 00 Participants | 0 Participants |
| Age, Categorical >=65 years | 00 Participants | 00 Participants | 00 Participants | 00 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 20 Participants | 20 Participants | 80 Participants |
| Age Continuous | 42.0 years STANDARD_DEVIATION 6.44 | 40.66 years STANDARD_DEVIATION 6.74 | 45.0 years STANDARD_DEVIATION 3.94 | 43.33 years STANDARD_DEVIATION 4.84 | 42.67 years STANDARD_DEVIATION 5.72 |
| Region of Enrollment Brazil | 20 participants | 20 participants | 20 participants | 20 participants | 80 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 20 Participants | 20 Participants | 20 Participants | 20 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 1 / 20 | 1 / 20 | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Drinking Days in the Previous Month
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Drinking Days in the Previous Month | Number of Drinking Days Baseline | 19.54 Days | Standard Deviation 9.85 |
| Placebo | Drinking Days in the Previous Month | Number of Drinking Days Final | 4.72 Days | Standard Deviation 8.74 |
| Naltrexone | Drinking Days in the Previous Month | Number of Drinking Days Final | 5.66 Days | Standard Deviation 7.48 |
| Naltrexone | Drinking Days in the Previous Month | Number of Drinking Days Baseline | 15.18 Days | Standard Deviation 10.32 |
| PUFAs | Drinking Days in the Previous Month | Number of Drinking Days Baseline | 17.75 Days | Standard Deviation 9.8 |
| PUFAs | Drinking Days in the Previous Month | Number of Drinking Days Final | 11.08 Days | Standard Deviation 12.87 |
| Naltrexone + PUFAs | Drinking Days in the Previous Month | Number of Drinking Days Baseline | 22.11 Days | Standard Deviation 11.63 |
| Naltrexone + PUFAs | Drinking Days in the Previous Month | Number of Drinking Days Final | 11.12 Days | Standard Deviation 13.74 |
Comparison: TIME COMPARISONp-value: <0.001ANOVA
Comparison: GROUP COMPARISONp-value: 0.69ANOVA
Secondary
Obsessive Compulsive Drinking Scale (OCDS)
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Obsessive Compulsive Drinking Scale (OCDS) | OCDS Baseline | 45.36 Units on a Scale | Standard Deviation 9.86 |
| Placebo | Obsessive Compulsive Drinking Scale (OCDS) | OCDS Final | 13.18 Units on a Scale | Standard Deviation 14.98 |
| Naltrexone | Obsessive Compulsive Drinking Scale (OCDS) | OCDS Final | 11.81 Units on a Scale | Standard Deviation 15.09 |
| Naltrexone | Obsessive Compulsive Drinking Scale (OCDS) | OCDS Baseline | 42.45 Units on a Scale | Standard Deviation 12.56 |
| PUFAs | Obsessive Compulsive Drinking Scale (OCDS) | OCDS Baseline | 36.5 Units on a Scale | Standard Deviation 14.88 |
| PUFAs | Obsessive Compulsive Drinking Scale (OCDS) | OCDS Final | 19.16 Units on a Scale | Standard Deviation 20.93 |
| Naltrexone + PUFAs | Obsessive Compulsive Drinking Scale (OCDS) | OCDS Baseline | 37.55 Units on a Scale | Standard Deviation 10.47 |
| Naltrexone + PUFAs | Obsessive Compulsive Drinking Scale (OCDS) | OCDS Final | 14.00 Units on a Scale | Standard Deviation 13.7 |
Comparison: TIME COMPARISONp-value: <0.001ANOVA
Comparison: GROUP COMPARISONp-value: 0.37ANOVA
Secondary
Short Alcohol Dependence Data Questionnaire (SADD)
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Short Alcohol Dependence Data Questionnaire (SADD) | SADD Final | 7.81 Units on a Scale | Standard Deviation 11.93 |
| Placebo | Short Alcohol Dependence Data Questionnaire (SADD) | SADD Baseline | 34.90 Units on a Scale | Standard Deviation 8.93 |
| Naltrexone | Short Alcohol Dependence Data Questionnaire (SADD) | SADD Baseline | 33.81 Units on a Scale | Standard Deviation 9.92 |
| Naltrexone | Short Alcohol Dependence Data Questionnaire (SADD) | SADD Final | 11.36 Units on a Scale | Standard Deviation 14.29 |
| PUFAs | Short Alcohol Dependence Data Questionnaire (SADD) | SADD Final | 7.81 Units on a Scale | Standard Deviation 11.93 |
| PUFAs | Short Alcohol Dependence Data Questionnaire (SADD) | SADD Baseline | 31.91 Units on a Scale | Standard Deviation 10.99 |
| Naltrexone + PUFAs | Short Alcohol Dependence Data Questionnaire (SADD) | SADD Final | 9.16 Units on a Scale | Standard Deviation 11.16 |
| Naltrexone + PUFAs | Short Alcohol Dependence Data Questionnaire (SADD) | SADD Baseline | 29.33 Units on a Scale | Standard Deviation 11.11 |
Comparison: TIME COMPARISONp-value: <0.001ANOVA
Comparison: GROUP COMPARISONp-value: 0.53ANOVA