Trial Outcomes & Findings for Evaluating the Safety of Acute Baclofen in Methadone-maintained Individuals With Opiate Dependence. (NCT NCT05161351)
NCT ID: NCT05161351
Last Updated: 2024-11-18
Results Overview
The maximum safe dose of baclofen at which 15-25% of evaluable participants experience a dose limiting toxicity (DLT) for prescribed doses of methadone
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
16 participants
Primary outcome timeframe
up to 24 hours after dosing
Results posted on
2024-11-18
Participant Flow
The study recruited only 16 patients in the end, as the primary outcome measure was met, and each person from the 16 patients only received one dose.
Participant milestones
| Measure |
Period 1 Baclofen 10mg
Participants will receive a single dose of 10mg of Baclofen administered as oral tablets.
Baclofen: Baclofen is the only selective GABA-B agonist licensed for human use. Originally developed as a potential anti-epileptic in the 1920s, it was found to have anti-spastic effects and is currently used for the treatment of spastic movement, especially in instances of spinal cord injury, spastic diplegia, multiple sclerosis, and amyotrophic lateral sclerosis.
|
Vitamin D3
Participants will receive a single dose of either 20μg (to match period 1), 60μg (to match period 2) or 120μg (to match period 3) of Vitamin D3 administered as oral tablets.
Vitamin D3: Placebo tablets will be vitamin D3, (colecalciferol).
|
Period 2 Baclofen 30mg
Participants will receive a single dose of 30mg of Baclofen.
|
Period 3 Baclofen 60mg
Participants will receive a single dose of 60mg of Baclofen
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
5
|
4
|
|
Overall Study
COMPLETED
|
3
|
4
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating the Safety of Acute Baclofen in Methadone-maintained Individuals With Opiate Dependence.
Baseline characteristics by cohort
| Measure |
Baclofen 10mg
n=3 Participants
Participants will receive a single dose of 10mg of Baclofen administered as oral tablets.
Baclofen: Baclofen is the only selective GABA-B agonist licensed for human use. Originally developed as a potential anti-epileptic in the 1920s, it was found to have anti-spastic effects and is currently used for the treatment of spastic movement, especially in instances of spinal cord injury, spastic diplegia, multiple sclerosis, and amyotrophic lateral sclerosis.
|
Vitamin D3
n=4 Participants
Participants will receive a single dose of either 20μg, 60μg or 120μg of Vitamin D3 administered as oral tablets.
Vitamin D3: Placebo tablets will be vitamin D3, (colecalciferol).
|
Baclofen 30mg
n=5 Participants
Participants will receive a single dose of 30mg of Baclofen administered as oral tablets.
|
Baclofen 60mg
n=4 Participants
Participants will receive a single dose of 60mg of Baclofen administered as oral tablets.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
48.7 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
46 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
45.8 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
47.5 years
STANDARD_DEVIATION 6.4 • n=4 Participants
|
46.8 years
STANDARD_DEVIATION 8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
4 participants
n=4 Participants
|
16 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: up to 24 hours after dosingThe maximum safe dose of baclofen at which 15-25% of evaluable participants experience a dose limiting toxicity (DLT) for prescribed doses of methadone
Outcome measures
| Measure |
Baclofen 10mg
n=3 Participants
Participants will receive a single dose of 10mg of Baclofen administered as oral tablets.
Baclofen: Baclofen is the only selective GABA-B agonist licensed for human use. Originally developed as a potential anti-epileptic in the 1920s, it was found to have anti-spastic effects and is currently used for the treatment of spastic movement, especially in instances of spinal cord injury, spastic diplegia, multiple sclerosis, and amyotrophic lateral sclerosis.
|
Vitamin D3
n=4 Participants
Participants will receive a single dose of either 20μg, 60μg or 120μg of Vitamin D3 administered as oral tablets.
Vitamin D3: Placebo tablets will be vitamin D3, (colecalciferol).
|
Baclofen 30mg
n=5 Participants
Participants will receive 30mg of baclofen
|
Baclofen 60mg
n=4 Participants
Participants will receive 60mg of Baclofen
|
|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Baclofen 10mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vitamin D3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Baclofen 30mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Baclofen 60mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Baclofen 10mg
n=3 participants at risk
Participants will receive a single dose of 30mg of Baclofen administered as oral tablets.
Baclofen: Baclofen is the only selective GABA-B agonist licensed for human use. Originally developed as a potential anti-epileptic in the 1920s, it was found to have anti-spastic effects and is currently used for the treatment of spastic movement, especially in instances of spinal cord injury, spastic diplegia, multiple sclerosis, and amyotrophic lateral sclerosis.
|
Vitamin D3
n=4 participants at risk
Participants will receive a single dose of either 20μg, 60μg or 120μg of Vitamin D3 administered as oral tablets.
Vitamin D3: Placebo tablets will be vitamin D3, (colecalciferol).
|
Baclofen 30mg
n=5 participants at risk
Participants will receive a single dose of 30mg of Baclofen administered as oral tablets
|
Baclofen 60mg
n=4 participants at risk
Participants will receive a single dose of 60mg of Baclofen administered as oral tablets
|
|---|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • Study day and following morning.
|
25.0%
1/4 • Number of events 1 • Study day and following morning.
|
0.00%
0/5 • Study day and following morning.
|
0.00%
0/4 • Study day and following morning.
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/3 • Study day and following morning.
|
0.00%
0/4 • Study day and following morning.
|
0.00%
0/5 • Study day and following morning.
|
25.0%
1/4 • Number of events 1 • Study day and following morning.
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/3 • Study day and following morning.
|
0.00%
0/4 • Study day and following morning.
|
20.0%
1/5 • Number of events 1 • Study day and following morning.
|
25.0%
1/4 • Number of events 1 • Study day and following morning.
|
|
General disorders
chills
|
0.00%
0/3 • Study day and following morning.
|
0.00%
0/4 • Study day and following morning.
|
0.00%
0/5 • Study day and following morning.
|
25.0%
1/4 • Number of events 1 • Study day and following morning.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Study day and following morning.
|
0.00%
0/4 • Study day and following morning.
|
20.0%
1/5 • Number of events 1 • Study day and following morning.
|
0.00%
0/4 • Study day and following morning.
|
|
Nervous system disorders
Sedation
|
0.00%
0/3 • Study day and following morning.
|
0.00%
0/4 • Study day and following morning.
|
40.0%
2/5 • Number of events 2 • Study day and following morning.
|
50.0%
2/4 • Number of events 2 • Study day and following morning.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Study day and following morning.
|
0.00%
0/4 • Study day and following morning.
|
0.00%
0/5 • Study day and following morning.
|
25.0%
1/4 • Number of events 1 • Study day and following morning.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Study day and following morning.
|
0.00%
0/4 • Study day and following morning.
|
0.00%
0/5 • Study day and following morning.
|
25.0%
1/4 • Number of events 1 • Study day and following morning.
|
Additional Information
Agnese Zicari,Quality Assurance Facilitator
Imperial College London Faculty of Medicine
Phone: +44(0)2075946615
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place