Trial Outcomes & Findings for Naltrexone & SSRI in Alcoholics With Depression/PTSD (NCT NCT00338962)
NCT ID: NCT00338962
Last Updated: 2016-02-05
Results Overview
The OCDS is a 14-item (rated 0-4), self-administered questionnaire for characterizing and quantifying the obsessive and compulsive cognitive aspects of craving and heavy (alcoholic) drinking, such as drinking-related thought, urges to drink, and the ability to resist those thoughts and urges. A higher total score indicates higher craving and ranges from 0-48.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
88 participants
Primary outcome timeframe
beginning of treatment (week 1), and end of treatment (13 weeks)
Results posted on
2016-02-05
Participant Flow
Participant milestones
| Measure |
Paroxetine and Naltrexone
Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
paroxetine: paroxetine (40mg/day)
Naltrexone: 50 mg per day
|
Paroxetine and Placebo
Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.
paroxetine: paroxetine (40mg/day)
Placebo: placebo
|
Desipramine and Naltrexone
Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
desipramine: 200 mg per day
Naltrexone: 50 mg per day
|
Desipramine and Placebo
Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.
desipramine: 200 mg per day
Placebo: placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
20
|
22
|
24
|
|
Overall Study
COMPLETED
|
14
|
16
|
16
|
21
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
6
|
3
|
Reasons for withdrawal
| Measure |
Paroxetine and Naltrexone
Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
paroxetine: paroxetine (40mg/day)
Naltrexone: 50 mg per day
|
Paroxetine and Placebo
Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.
paroxetine: paroxetine (40mg/day)
Placebo: placebo
|
Desipramine and Naltrexone
Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
desipramine: 200 mg per day
Naltrexone: 50 mg per day
|
Desipramine and Placebo
Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.
desipramine: 200 mg per day
Placebo: placebo
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Overall Study
No Transportation
|
2
|
0
|
0
|
0
|
|
Overall Study
Time Constraint
|
2
|
0
|
0
|
0
|
|
Overall Study
Moved
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
0
|
|
Overall Study
Poor Compliance
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Naltrexone & SSRI in Alcoholics With Depression/PTSD
Baseline characteristics by cohort
| Measure |
Paroxetine and Naltrexone
n=22 Participants
Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
paroxetine: paroxetine (40mg/day)
Naltrexone: 50 mg per day
|
Paroxetine and Placebo
n=20 Participants
Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.
paroxetine: paroxetine (40mg/day)
Placebo: placebo
|
Desipramine and Naltrexone
n=22 Participants
Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
desipramine: 200 mg per day
Naltrexone: 50 mg per day
|
Desipramine and Placebo
n=24 Participants
Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.
desipramine: 200 mg per day
Placebo: placebo
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.14 years
STANDARD_DEVIATION 6.71 • n=99 Participants
|
49.15 years
STANDARD_DEVIATION 8.95 • n=107 Participants
|
47.05 years
STANDARD_DEVIATION 9.96 • n=206 Participants
|
47.04 years
STANDARD_DEVIATION 9.72 • n=7 Participants
|
47.1 years
STANDARD_DEVIATION 8.90 • n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
80 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: beginning of treatment (week 1), and end of treatment (13 weeks)The OCDS is a 14-item (rated 0-4), self-administered questionnaire for characterizing and quantifying the obsessive and compulsive cognitive aspects of craving and heavy (alcoholic) drinking, such as drinking-related thought, urges to drink, and the ability to resist those thoughts and urges. A higher total score indicates higher craving and ranges from 0-48.
Outcome measures
| Measure |
Paroxetine and Naltrexone
n=14 Participants
Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
paroxetine: paroxetine (40mg/day)
Naltrexone: 50 mg per day
|
Paroxetine and Placebo
n=16 Participants
Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.
paroxetine: paroxetine (40mg/day)
Placebo: placebo
|
Desipramine and Naltrexone
n=16 Participants
Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
desipramine: 200 mg per day
Naltrexone: 50 mg per day
|
Desipramine and Placebo
n=21 Participants
Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.
desipramine: 200 mg per day
Placebo: placebo
|
|---|---|---|---|---|
|
Mean Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS)
Week 1
|
21.273 units on a scale
Standard Error 2.547
|
20.700 units on a scale
Standard Error 2.672
|
18.500 units on a scale
Standard Error 2.547
|
21.458 units on a scale
Standard Error 2.439
|
|
Mean Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS)
Week 13
|
10.013 units on a scale
Standard Error 3.009
|
9.690 units on a scale
Standard Error 3.025
|
4.296 units on a scale
Standard Error 2.847
|
7.489 units on a scale
Standard Error 2.483
|
PRIMARY outcome
Timeframe: beginning of treatment (week 1), and end of treatment (13 weeks)The CAPS is the gold standard in PTSD assessment. The CAPS-5 is a 30-item structured interview that can be used to: Make current (past month) diagnosis of PTSD Make lifetime diagnosis of PTSD Assess PTSD symptoms over the past week Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). A higher score is associated with higher severity of PTSD. The score is interpreted as follows: 0-19=Asymptomatic/few symptoms 20-39=Sub-threshold/mild PTSD 40-59=Threshold PTSD/moderate 60-79=Severe PTSD \>80=Extreme PTSD
Outcome measures
| Measure |
Paroxetine and Naltrexone
n=14 Participants
Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
paroxetine: paroxetine (40mg/day)
Naltrexone: 50 mg per day
|
Paroxetine and Placebo
n=16 Participants
Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.
paroxetine: paroxetine (40mg/day)
Placebo: placebo
|
Desipramine and Naltrexone
n=16 Participants
Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
desipramine: 200 mg per day
Naltrexone: 50 mg per day
|
Desipramine and Placebo
n=21 Participants
Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.
desipramine: 200 mg per day
Placebo: placebo
|
|---|---|---|---|---|
|
Clinician-Administered PTSD Scale (CAPS)
Beginning of Treatment
|
73.54 units on a scale
Standard Error 5.007
|
69.810 units on a scale
Standard Error 5.166
|
62.500 units on a scale
Standard Error 5.047
|
77.833 units on a scale
Standard Error 4.832
|
|
Clinician-Administered PTSD Scale (CAPS)
End of Treatment
|
40.024 units on a scale
Standard Error 5.53
|
36.591 units on a scale
Standard Error 5.570
|
26.751 units on a scale
Standard Error 5.353
|
41.392 units on a scale
Standard Error 4.949
|
PRIMARY outcome
Timeframe: beginning of treatment (week 1), and end of treatment (13 weeks)The HAM-D ranges from 0 (Normal) to \>23 (Very Severe Depression)
Outcome measures
| Measure |
Paroxetine and Naltrexone
n=14 Participants
Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
paroxetine: paroxetine (40mg/day)
Naltrexone: 50 mg per day
|
Paroxetine and Placebo
n=16 Participants
Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.
paroxetine: paroxetine (40mg/day)
Placebo: placebo
|
Desipramine and Naltrexone
n=16 Participants
Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
desipramine: 200 mg per day
Naltrexone: 50 mg per day
|
Desipramine and Placebo
n=21 Participants
Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.
desipramine: 200 mg per day
Placebo: placebo
|
|---|---|---|---|---|
|
Hamilton Depression Rating Scale (HAM-D)
Beginning of Treatment
|
13.273 units on a scale
Standard Error 1.112
|
10.950 units on a scale
Standard Error 1.167
|
11.195 units on a scale
Standard Error 1.132
|
13.167 units on a scale
Standard Error 1.065
|
|
Hamilton Depression Rating Scale (HAM-D)
End of Treatment
|
9.328 units on a scale
Standard Error 1.256
|
8.238 units on a scale
Standard Error 1.299
|
8.563 units on a scale
Standard Error 1.201
|
8.943 units on a scale
Standard Error 1.117
|
PRIMARY outcome
Timeframe: 12 weeksDifferences in mean number of side effects reported for each group. Side effects and common adverse symptoms were evaluated by the research staff weekly, using a modified version of the ystematic Assessment for Treatment Emergent Events. The symptoms that are known to be associated with treatment with desipramine, paroxetine, and naltrexone were specifically screened or on a weekly basis. The symptoms were then clustered into the following categories: gastrointestinal, emotional, cold and flu symptoms, skin, sexual, neurological, and cardiac.
Outcome measures
| Measure |
Paroxetine and Naltrexone
n=22 Participants
Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
paroxetine: paroxetine (40mg/day)
Naltrexone: 50 mg per day
|
Paroxetine and Placebo
n=20 Participants
Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.
paroxetine: paroxetine (40mg/day)
Placebo: placebo
|
Desipramine and Naltrexone
n=22 Participants
Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
desipramine: 200 mg per day
Naltrexone: 50 mg per day
|
Desipramine and Placebo
n=24 Participants
Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.
desipramine: 200 mg per day
Placebo: placebo
|
|---|---|---|---|---|
|
Mean Number of Side Effects
Gastrointestinal symptoms
|
3.651 side effects
Standard Error .487
|
2.688 side effects
Standard Error .513
|
3.052 side effects
Standard Error .475
|
3.653 side effects
Standard Error .431
|
|
Mean Number of Side Effects
Emotional Symptoms
|
4.874 side effects
Standard Error .686
|
3.963 side effects
Standard Error .719
|
3.727 side effects
Standard Error .689
|
5.248 side effects
Standard Error .629
|
|
Mean Number of Side Effects
Neurological Symptoms
|
6.212 side effects
Standard Error 1.058
|
5.078 side effects
Standard Error 1.106
|
4.201 side effects
Standard Error 1.047
|
4.566 side effects
Standard Error .970
|
|
Mean Number of Side Effects
Cold Symptoms
|
2.182 side effects
Standard Error .490
|
2.393 side effects
Standard Error .512
|
1.891 side effects
Standard Error .483
|
2.253 side effects
Standard Error .447
|
|
Mean Number of Side Effects
Skin Symptoms
|
1.002 side effects
Standard Error .240
|
.859 side effects
Standard Error .252
|
.591 side effects
Standard Error .236
|
1.057 side effects
Standard Error .215
|
|
Mean Number of Side Effects
Sexual Symptoms
|
.877 side effects
Standard Error .241
|
.932 side effects
Standard Error .252
|
.737 side effects
Standard Error .238
|
.736 side effects
Standard Error .219
|
|
Mean Number of Side Effects
Cardiac Symptoms
|
.416 side effects
Standard Error .093
|
.474 side effects
Standard Error .101
|
.389 side effects
Standard Error .089
|
.356 side effects
Standard Error .076
|
Adverse Events
Paroxetine and Naltrexone
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Paroxetine and Placebo
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Desipramine and Naltrexone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Desipramine and Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paroxetine and Naltrexone
n=22 participants at risk
Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
paroxetine: paroxetine (40mg/day)
Naltrexone: 50 mg per day
|
Paroxetine and Placebo
n=20 participants at risk
Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.
paroxetine: paroxetine (40mg/day)
Placebo: placebo
|
Desipramine and Naltrexone
n=22 participants at risk
Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
desipramine: 200 mg per day
Naltrexone: 50 mg per day
|
Desipramine and Placebo
n=24 participants at risk
Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.
desipramine: 200 mg per day
Placebo: placebo
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Death
|
4.5%
1/22 • Number of events 1 • 9 weeks afters study medication
|
0.00%
0/20 • 9 weeks afters study medication
|
0.00%
0/22 • 9 weeks afters study medication
|
0.00%
0/24 • 9 weeks afters study medication
|
|
Nervous system disorders
Seizure
|
0.00%
0/22 • 9 weeks afters study medication
|
5.0%
1/20 • 9 weeks afters study medication
|
0.00%
0/22 • 9 weeks afters study medication
|
0.00%
0/24 • 9 weeks afters study medication
|
|
Psychiatric disorders
Hospitalized for severe anxiety
|
0.00%
0/22 • 9 weeks afters study medication
|
5.0%
1/20 • 9 weeks afters study medication
|
0.00%
0/22 • 9 weeks afters study medication
|
0.00%
0/24 • 9 weeks afters study medication
|
Other adverse events
| Measure |
Paroxetine and Naltrexone
n=22 participants at risk
Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
paroxetine: paroxetine (40mg/day)
Naltrexone: 50 mg per day
|
Paroxetine and Placebo
n=20 participants at risk
Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.
paroxetine: paroxetine (40mg/day)
Placebo: placebo
|
Desipramine and Naltrexone
n=22 participants at risk
Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.
desipramine: 200 mg per day
Naltrexone: 50 mg per day
|
Desipramine and Placebo
n=24 participants at risk
Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.
desipramine: 200 mg per day
Placebo: placebo
|
|---|---|---|---|---|
|
Nervous system disorders
Dizziness and Lightheadedness
|
0.00%
0/22 • 9 weeks afters study medication
|
0.00%
0/20 • 9 weeks afters study medication
|
9.1%
2/22 • 9 weeks afters study medication
|
0.00%
0/24 • 9 weeks afters study medication
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/22 • 9 weeks afters study medication
|
0.00%
0/20 • 9 weeks afters study medication
|
0.00%
0/22 • 9 weeks afters study medication
|
4.2%
1/24 • 9 weeks afters study medication
|
|
General disorders
Incarcerated for intoxication
|
4.5%
1/22 • 9 weeks afters study medication
|
0.00%
0/20 • 9 weeks afters study medication
|
0.00%
0/22 • 9 weeks afters study medication
|
4.2%
1/24 • 9 weeks afters study medication
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/22 • 9 weeks afters study medication
|
5.0%
1/20 • 9 weeks afters study medication
|
0.00%
0/22 • 9 weeks afters study medication
|
0.00%
0/24 • 9 weeks afters study medication
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place