Change in Self-reported Cue-elicited Drug Craving as Measured by Visual Analog Scale (VAS)
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Investigational Group | -5.00 | NA |
| Control Group | -13.34 | 19.58 |
Trial · Interventional
CompletedPhase 1/2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This research is being done to find out if liraglutide (brand name is Saxenda®) can safely and effectively reduce craving for opioids in patients with opioid use disorder, a primary factor contributing to early relapse.
Experimental
Investigational group
Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.
Placebo comparator
Control group
Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.
Outcomes the sponsor listed as primary.
Change in Self-reported Cue-elicited Drug Craving as Measured by Visual Analog Scale (VAS)
Time frame · Baseline (Day 1), End of the target drug dose (Day 19)
Scores are measured on a 0-100 point VAS, where 0= no craving, 100= maximum craving.
Change in Ambient Drug Craving Over Time as Measured by Visual Analog Scale (VAS)
Time frame · Baseline (Day 1), Treatment Days (Days 2-19)
Scores are measured on a 0-4 point VAS, where 0= no craving, 4= maximum craving.
Change in Blood Pressure
Time frame · Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)
Blood pressure measurements in mmHg. Both systolic and diastolic pressures will be assessed during the study period.
Change in Heart Rate
Time frame · Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)
Heart rate measurements in beats per minute.
Change in Respiratory Rate
Time frame · Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)
Respiratory rate in breaths per minute.
Absolute Change in Body Weight
Time frame · From Day 1 to Day 19
Body weight will be measured in kilograms (kg).
Percent Change in Body Weight
Time frame · From Day 1 to Day 19
Body weight will be measured in kilograms (kg) and change will measured in %.
Change in Fasting Blood Samples for Fructosamine
Time frame · From Day 2 to Day 19
Fructosamine is measured in umol/L
Change in Fasting Blood Samples for HA1c
Time frame · From Day 2 to Day 19
HA1c is measured in %
Frequency of Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame · Days 1-21 and at 30 days post-intervention (Day 49).
Number of participants affected by probable drug-related adverse events.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Investigational Group | -5.00 | NA |
| Control Group | -13.34 | 19.58 |
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Investigational Group | -0.55 | NA |
| Control Group | -1.41 | 0.99 |
| Group | Value (mmHg) | Spread |
|---|---|---|
| Investigational Group | 4.00 | NA |
| Control Group | -0.59 | 4.69 |
| Group | Value (beats per minute) | Spread |
|---|---|---|
| Investigational Group | 10.75 | NA |
| Control Group | -5.78 | 5.10 |
| Group | Value (breaths per minute) | Spread |
|---|---|---|
| Investigational Group | -1.00 | NA |
| Control Group | 0.08 | 2.83 |
| Group | Value (kg) | Spread |
|---|---|---|
| Investigational Group | 0.27 | NA |
| Control Group | 1.05 | 1.86 |
| Group | Value (% change) | Spread |
|---|---|---|
| Investigational Group | 0.33 | NA |
| Control Group | 1.38 | 2.39 |
| Group | Value (umol/L) | Spread |
|---|---|---|
| Investigational Group | -14.00 | NA |
| Control Group | 2.71 | 21.48 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Investigational GroupParticipants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen. Liraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer | 0 / 12 | 2 / 12 | 10 / 12 |
| Control GroupParticipants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day. Placebo: Placebo injection pen | 0 / 13 | 1 / 13 | 8 / 13 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
0 studies on this page
Indexing hint: Clinical trial · 2024
Freet et al. 2024Addiction science & clinical practicecited by 18
PMID 39061093PMC11282646DOI 10.1186/s13722-024-00481-7PUB-39061093
Who could join, as posted.
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