Trial Outcomes & Findings for VIVITROL as a Treatment for Cocaine and Alcohol Dependence (NCT NCT00777062)
NCT ID: NCT00777062
Last Updated: 2018-01-26
Results Overview
Percentage of subjects with no cocaine use for at least 3 weeks
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
8 week medication phase
Results posted on
2018-01-26
Participant Flow
Participant milestones
| Measure |
Vivitrol
VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
|
Placebo
Placebo injection, 380 mg injection at the start of weeks 2 and 6.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
41
|
|
Overall Study
COMPLETED
|
36
|
36
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
VIVITROL as a Treatment for Cocaine and Alcohol Dependence
Baseline characteristics by cohort
| Measure |
Vivitrol
n=39 Participants
VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
|
Placebo
n=41 Participants
Placebo injection, 380 mg injection at the start of weeks 2 and 6.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
47.5 years
STANDARD_DEVIATION 7.0 • n=99 Participants
|
48.4 years
STANDARD_DEVIATION 6.3 • n=107 Participants
|
47.9 years
STANDARD_DEVIATION 6.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=99 Participants
|
41 participants
n=107 Participants
|
80 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 8 week medication phasePercentage of subjects with no cocaine use for at least 3 weeks
Outcome measures
| Measure |
Vivitrol
n=39 Participants
VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
|
Placebo
n=41 Participants
Placebo injection, 380 mg injection at the start of weeks 2 and 6.
|
|---|---|---|
|
Urine Assay for Benzoylecgonine (BE), the Primary Metabolite of Cocaine.
|
33.3 Percentage of Participants
|
31.7 Percentage of Participants
|
PRIMARY outcome
Timeframe: 8 week medication phasePercentage of participants who were abstinent from drinking
Outcome measures
| Measure |
Vivitrol
n=39 Participants
VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
|
Placebo
n=41 Participants
Placebo injection, 380 mg injection at the start of weeks 2 and 6.
|
|---|---|---|
|
Time Line Follow Back -Reported Days of Abstinence From Drinking
|
10.3 Percentage of Participants
|
17.1 Percentage of Participants
|
Adverse Events
Vivitrol
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vivitrol
n=39 participants at risk
VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
|
Placebo
n=41 participants at risk
Placebo injection, 380 mg injection at the start of weeks 2 and 6.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
|
Psychiatric disorders
Hospitalization for Depression
|
2.6%
1/39 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
General disorders
Hospitalization for pneumonia
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
|
General disorders
Worsening of addiction symptoms
|
2.6%
1/39 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lacerations and fractured rib
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
Hospitalization for nausea and vomiting
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
|
Injury, poisoning and procedural complications
Hospitalization for an overdose of tylenol
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
Other adverse events
| Measure |
Vivitrol
n=39 participants at risk
VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
|
Placebo
n=41 participants at risk
Placebo injection, 380 mg injection at the start of weeks 2 and 6.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Swelling at the injection site
|
56.4%
22/39
|
31.7%
13/41
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place