Trial Outcomes & Findings for Dronabinol Naltrexone Treatment for Opioid Dependence (NCT NCT01024335)
NCT ID: NCT01024335
Last Updated: 2018-06-18
Results Overview
The Subjective Opiate Withdrawal Scale is a self-administered 16 scale containing 16 symptoms ranging in severity from 0 (not at all) to 4 (extremely). The SOWS total score is the sum of 16 items, ranging from 0 (no opiate withdrawal ) to 64 ( severe opiate withdrawal). Values from multiple assessments during the 8-week outpatient phase were averaged.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
60 participants
Primary outcome timeframe
3x/week during 8 weeks of the trial or study participation
Results posted on
2018-06-18
Participant Flow
Participant milestones
| Measure |
Naltrexone and Placebo
A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.
Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks.
|
Naltrexone and Dronabinol
A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.
Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
40
|
|
Overall Study
COMPLETED
|
7
|
14
|
|
Overall Study
NOT COMPLETED
|
13
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dronabinol Naltrexone Treatment for Opioid Dependence
Baseline characteristics by cohort
| Measure |
Naltrexone and Placebo
n=20 Participants
A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.
Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks.
|
Naltrexone and Dronabinol
n=40 Participants
A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.
Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.3 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
38.5 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
38.1 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
12 participants
n=5 Participants
|
23 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
5 participants
n=5 Participants
|
13 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3x/week during 8 weeks of the trial or study participationThe Subjective Opiate Withdrawal Scale is a self-administered 16 scale containing 16 symptoms ranging in severity from 0 (not at all) to 4 (extremely). The SOWS total score is the sum of 16 items, ranging from 0 (no opiate withdrawal ) to 64 ( severe opiate withdrawal). Values from multiple assessments during the 8-week outpatient phase were averaged.
Outcome measures
| Measure |
Naltrexone and Placebo
n=20 Participants
A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.
Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks.
|
Naltrexone and Dronabinol
n=40 Participants
A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.
Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment.
|
|---|---|---|
|
Opiate Withdrawal Measured by the Subjective Opiate Withdrawal Scale (SOWS) .
|
11.16 units on a scale
Standard Deviation 6.13
|
13.36 units on a scale
Standard Deviation 10.55
|
PRIMARY outcome
Timeframe: retention over 8 weeks.Of those participants randomized to the naltrexone and dronabinol arm, the number that completed all 8 weeks of treatment.
Outcome measures
| Measure |
Naltrexone and Placebo
n=20 Participants
A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.
Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks.
|
Naltrexone and Dronabinol
n=40 Participants
A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.
Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment.
|
|---|---|---|
|
Retention
|
7 participants
|
14 participants
|
Adverse Events
Naltrexone and Placebo
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Naltrexone and Dronabinol
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Naltrexone and Placebo
n=20 participants at risk
A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.
Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks.
|
Naltrexone and Dronabinol
n=40 participants at risk
A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.
Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment.
|
|---|---|---|
|
General disorders
Pruritis and facial swelling
|
0.00%
0/20
|
2.5%
1/40 • Number of events 1
|
|
General disorders
Dehydration
|
5.0%
1/20 • Number of events 1
|
0.00%
0/40
|
|
General disorders
Kidney infection and dislocated arm
|
5.0%
1/20 • Number of events 1
|
0.00%
0/40
|
Other adverse events
| Measure |
Naltrexone and Placebo
n=20 participants at risk
A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.
Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks.
|
Naltrexone and Dronabinol
n=40 participants at risk
A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.
Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment.
|
|---|---|---|
|
Psychiatric disorders
Insomnia
|
35.0%
7/20 • Number of events 7
|
42.5%
17/40 • Number of events 17
|
|
Psychiatric disorders
Mood changes
|
20.0%
4/20 • Number of events 4
|
12.5%
5/40 • Number of events 5
|
|
General disorders
Increased/decreased appetite
|
10.0%
2/20 • Number of events 2
|
5.0%
2/40 • Number of events 2
|
|
Gastrointestinal disorders
Nausea/vomiting
|
10.0%
2/20 • Number of events 2
|
12.5%
5/40 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
2/20 • Number of events 2
|
17.5%
7/40 • Number of events 7
|
|
General disorders
Headache
|
10.0%
2/20 • Number of events 2
|
7.5%
3/40 • Number of events 3
|
|
General disorders
Body Aches
|
5.0%
1/20 • Number of events 1
|
7.5%
3/40 • Number of events 3
|
|
Gastrointestinal disorders
GI Distress
|
15.0%
3/20 • Number of events 3
|
10.0%
4/40 • Number of events 4
|
|
General disorders
Sweating/chills
|
0.00%
0/20
|
10.0%
4/40 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place