Trial Outcomes & Findings for Treatment Study Using Depot Naltrexone (1/6) Philadelphia Coord/Data Mgmt Site (NCT NCT00781898)
NCT ID: NCT00781898
Last Updated: 2017-10-23
Results Overview
A relapse event was defined as 10 or more days of opioid use in a 28-day (4-week) period as assessed by self-report or by testing of urine samples obtained every 2 weeks; a positive or missing sample was computed as 5 days of opioid use.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
308 participants
Primary outcome timeframe
6 months
Results posted on
2017-10-23
Participant Flow
Community-dwelling adult volunteers who had been incarcerated and who had a history of opioid dependence.
Participant milestones
| Measure |
Depot Naltrexone
Depot naltrexone: Vivitrol® extended release naltrexone 380 mg per month delivered in monthly intramuscular injections.
|
Placebo
Treatment as Usual (TAU): Treatment as Usual (TAU) community treatment provided to the participant
|
|---|---|---|
|
Overall Study
STARTED
|
153
|
155
|
|
Overall Study
COMPLETED
|
119
|
126
|
|
Overall Study
NOT COMPLETED
|
34
|
29
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment Study Using Depot Naltrexone (1/6) Philadelphia Coord/Data Mgmt Site
Baseline characteristics by cohort
| Measure |
Depot Naltrexone
n=153 Participants
Participants who were randomized to receive Extended Release Naltrexone
|
Placebo
n=155 Participants
Treatment as Usual (TAU): Treatment as Usual (TAU) community treatment provided to the participant
|
Total
n=308 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
153 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
308 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
43 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
43.5 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
129 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
261 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
153 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
308 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsA relapse event was defined as 10 or more days of opioid use in a 28-day (4-week) period as assessed by self-report or by testing of urine samples obtained every 2 weeks; a positive or missing sample was computed as 5 days of opioid use.
Outcome measures
| Measure |
Depot Naltrexone
n=153 Participants
Depot naltrexone: Vivitrol® extended release naltrexone 380 mg per month delivered in monthly intramuscular injections.
|
Placebo
n=155 Participants
Treatment as Usual (TAU): Treatment as Usual (TAU) community treatment provided to the participant
|
|---|---|---|
|
Relapse
|
66 Participants
|
99 Participants
|
Adverse Events
Depot Naltrexone
Serious events: 16 serious events
Other events: 29 other events
Deaths: 2 deaths
Placebo
Serious events: 45 serious events
Other events: 13 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Depot Naltrexone
n=153 participants at risk
Depot naltrexone: Vivitrol® extended release naltrexone 380 mg per month delivered in monthly intramuscular injections.
|
Placebo
n=155 participants at risk
Treatment as Usual (TAU): Treatment as Usual (TAU) community treatment provided to the participant
|
|---|---|---|
|
Psychiatric disorders
Depression or suicidality
|
2.0%
3/153 • 18 months
Adverse Events were assessed at each study visit
|
3.9%
6/155 • 18 months
Adverse Events were assessed at each study visit
|
|
Cardiac disorders
Chest pain
|
1.3%
2/153 • 18 months
Adverse Events were assessed at each study visit
|
2.6%
4/155 • 18 months
Adverse Events were assessed at each study visit
|
|
General disorders
Death
|
1.3%
2/153 • 18 months
Adverse Events were assessed at each study visit
|
3.2%
5/155 • 18 months
Adverse Events were assessed at each study visit
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal symptom
|
1.3%
2/153 • 18 months
Adverse Events were assessed at each study visit
|
2.6%
4/155 • 18 months
Adverse Events were assessed at each study visit
|
|
Cardiac disorders
Stroke
|
1.3%
2/153 • 18 months
Adverse Events were assessed at each study visit
|
0.00%
0/155 • 18 months
Adverse Events were assessed at each study visit
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
0.00%
0/153 • 18 months
Adverse Events were assessed at each study visit
|
3.2%
5/155 • 18 months
Adverse Events were assessed at each study visit
|
|
Skin and subcutaneous tissue disorders
Abscess
|
0.00%
0/153 • 18 months
Adverse Events were assessed at each study visit
|
2.6%
4/155 • 18 months
Adverse Events were assessed at each study visit
|
|
General disorders
Nonfatal Overdose
|
0.00%
0/153 • 18 months
Adverse Events were assessed at each study visit
|
2.6%
4/155 • 18 months
Adverse Events were assessed at each study visit
|
|
General disorders
Exacerbation of Pre-existing condition
|
0.00%
0/153 • 18 months
Adverse Events were assessed at each study visit
|
1.9%
3/155 • 18 months
Adverse Events were assessed at each study visit
|
|
Surgical and medical procedures
Surgery for Colon Cancer
|
0.00%
0/153 • 18 months
Adverse Events were assessed at each study visit
|
1.3%
2/155 • 18 months
Adverse Events were assessed at each study visit
|
|
General disorders
Any Overdose
|
0.00%
0/153 • 18 months
Adverse Events were assessed at each study visit
|
4.5%
7/155 • 18 months
Adverse Events were assessed at each study visit
|
|
General disorders
Fatal Overdose
|
0.00%
0/153 • 18 months
Adverse Events were assessed at each study visit
|
1.9%
3/155 • 18 months
Adverse Events were assessed at each study visit
|
|
General disorders
Stroke
|
0.65%
1/153 • 18 months
Adverse Events were assessed at each study visit
|
0.00%
0/155 • 18 months
Adverse Events were assessed at each study visit
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.65%
1/153 • 18 months
Adverse Events were assessed at each study visit
|
0.65%
1/155 • 18 months
Adverse Events were assessed at each study visit
|
|
General disorders
Dehydration
|
0.65%
1/153 • 18 months
Adverse Events were assessed at each study visit
|
0.00%
0/155 • 18 months
Adverse Events were assessed at each study visit
|
|
Renal and urinary disorders
Acute Renal failure
|
0.65%
1/153 • 18 months
Adverse Events were assessed at each study visit
|
0.00%
0/155 • 18 months
Adverse Events were assessed at each study visit
|
|
General disorders
Opioid Withdrawal
|
0.65%
1/153 • 18 months
Adverse Events were assessed at each study visit
|
0.00%
0/155 • 18 months
Adverse Events were assessed at each study visit
|
|
General disorders
Hospitalization Unknown
|
0.65%
1/153 • 18 months
Adverse Events were assessed at each study visit
|
0.00%
0/155 • 18 months
Adverse Events were assessed at each study visit
|
Other adverse events
| Measure |
Depot Naltrexone
n=153 participants at risk
Depot naltrexone: Vivitrol® extended release naltrexone 380 mg per month delivered in monthly intramuscular injections.
|
Placebo
n=155 participants at risk
Treatment as Usual (TAU): Treatment as Usual (TAU) community treatment provided to the participant
|
|---|---|---|
|
General disorders
Headache
|
19.0%
29/153 • 18 months
Adverse Events were assessed at each study visit
|
8.4%
13/155 • 18 months
Adverse Events were assessed at each study visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place