Trial · NCT04470050

Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal

NCT04470050, Phase 1, Phase 2, Completed, BioXcel Therapeutics Inc; results first posted 2023-10-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal. Trials, record NCT04470050. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04470050

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal
NCT number: NCT04470050
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 225 participants, actual
Lead sponsor: BioXcel Therapeutics Inc
Conditions: Opioid Withdrawal
Interventions: Dexmedetomidine, Placebo
First posted: 2020-07-14
Last updated: 2026-08-11
Results first posted: 2023-10-26

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Peak SOWS Scores at Baseline and Over Time	Baseline (pre-dose day 6) and at days 6, 7, 8, 9, 10, 11, 12, 13, and 14 post-dose	Short Opiate Withdrawal Scale (SOWS)-Gossop: The SOWs scale is a validated 10-item patient-reported scale designed to measure the symptoms of withdrawal in subjects who are dependent on opioids. Each of the 10 items represents a symptom: "feeling sick," "stomach cramps," "muscle spasms/twitching," "feeling of coldness," "heart pounding," "muscular tension," "aches and pains," "yawning," "runny eyes," and "insomnia/problems sleeping." Scores on the SOWS-Gossop can range from 0 to 30, with higher scores indicating greater severity of withdrawal symptoms.
Secondary	Peak COWS Score at Baseline and Over Time	Baseline (pre-dose day 6) and at days 6, 7, 8, 9, 10, 11, 12, 13, and 14 post-dose	Clinical Opiate Withdrawal Scale (COWS): The COWS scale is a validated, 11-item questionnaire designed to quantify withdrawal symptoms. Symptoms evaluated include resting pulse rate, sweating, restlessness, pupil size, bone or joint aches, runny nose or tearing, gastrointestinal upset, tremor, yawning, anxiety or irritability, and gooseflesh. COWS total scores range from 0 to 48, with 5 to 12 indicating mild symptoms, 13 to 24 indicating moderate symptoms, 25 to 36 indicating moderately severe symptoms, and greater than 36 indicating severe symptoms.
Secondary	Average COWS Scores at Baseline and Over Time	Baseline (pre-dose day 6) and at days 6, 7, 8, 9, 10, 11, 12, 13, and 14 post-dose	Clinical Opiate Withdrawal Scale (COWS): The COWs scale is a validated, 11-item questionnaire designed to quantify withdrawal symptoms. Symptoms evaluated include resting pulse rate, sweating, restlessness, pupil size, bone or joint aches, runny nose or tearing, gastrointestinal upset, tremor, yawning, anxiety or irritability, and gooseflesh. COWS total scores range from 0 to 48, with 5 to 12 indicating mild symptoms, 13 to 24 indicating moderate symptoms, 25 to 36 indicating moderately severe symptoms, and greater than 36 indicating severe symptoms.
Secondary	Average SOWS at Baseline and Over Time	Baseline (pre-dose day 6) and at days 6, 7, 8, 9, 10, 11, 12, 13, and 14 post-dose	Short Opiate Withdrawal Scale (SOWS)-Gossop: The SOWs scale is a validated 10-item patient-reported scale designed to measure the symptoms of withdrawal in subjects who are dependent on opioids.5 Each of the 10 items represents a symptom: "feeling sick," "stomach cramps," "muscle spasms/twitching," "feeling of coldness," "heart pounding," "muscular tension," "aches and pains," "yawning," "runny eyes," and "insomnia/problems sleeping." Scores on the SOWS-Gossop can range from 0 to 30, with higher scores indicating greater severity of withdrawal symptoms.
Secondary	Time to Drop-out After Discontinuation of Opioid Maintenance Phase	Day 6 through Day 14	Time to drop-out during double-blind treatment phase after discontinuation of opioid maintenance Phase.
Secondary	Number and Percentage of Subject Drop-out After Discontinuation of Opioid Maintenance Phase Maintenance Within Each Treatment Group	Day 6 through Day 14	Number and Percentage of Subject Drop-out after Discontinuation of Opioid Maintenance Phase Within Each Treatment Group Between Days 6-14.
Secondary	Total ACES Total Score Over Time - 2 hr. Post-First Dose	Post-Dose Day 6 to Day 12	Overall Agitation-Calmness Evaluation Scale (ACES): The ACES scale is a single-item measure rating overall agitation and sedation, ranging from 1 (marked agitation) to 9 (unarousable). This outcome measures the total ACES total score over time at 2 hours, post-first dose.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Peak SOWS Scores at Baseline and Over Time	Baseline (pre-dose day 6) and at days 6, 7, 8, 9, 10, 11, 12, 13, and 14 post-dose	Full Analysis Set (FAS)	score on a scale	MEAN
SECONDARY	Peak COWS Score at Baseline and Over Time	Baseline (pre-dose day 6) and at days 6, 7, 8, 9, 10, 11, 12, 13, and 14 post-dose	Full Analysis Set (FAS):	score on a scale	MEAN
SECONDARY	Average COWS Scores at Baseline and Over Time	Baseline (pre-dose day 6) and at days 6, 7, 8, 9, 10, 11, 12, 13, and 14 post-dose	Full Analysis Set (FAS)	score on a scale	MEAN
SECONDARY	Average SOWS at Baseline and Over Time	Baseline (pre-dose day 6) and at days 6, 7, 8, 9, 10, 11, 12, 13, and 14 post-dose	Full Analysis Set (FAS)	score on a scale	MEAN
SECONDARY	Time to Drop-out After Discontinuation of Opioid Maintenance Phase	Day 6 through Day 14	Full Analysis Set (FAS)	Days	MEDIAN
SECONDARY	Number and Percentage of Subject Drop-out After Discontinuation of Opioid Maintenance Phase Maintenance Within Each Treatment Group	Day 6 through Day 14	Full Analysis Set (FAS)	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Total ACES Total Score Over Time - 2 hr. Post-First Dose	Post-Dose Day 6 to Day 12	Full Analysis Set (FAS)	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group399

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Peak SOWS Scores at Baseline and Over Time	30 Micrograms	Baseline, Pre-Dose, Day 6	3.6	Standard Deviation 3.24	score on a scale
Peak SOWS Scores at Baseline and Over Time	60 Micrograms	Baseline, Pre-Dose, Day 6	5.2	Standard Deviation 3.86	score on a scale
Peak SOWS Scores at Baseline and Over Time	90 Micrograms	Baseline, Pre-Dose, Day 6	6.0	Standard Deviation 5.45	score on a scale
Peak SOWS Scores at Baseline and Over Time	120 Micrograms	Baseline, Pre-Dose, Day 6	4.7	Standard Deviation 4.64	score on a scale
Peak SOWS Scores at Baseline and Over Time	180 Micrograms	Baseline, Pre-Dose, Day 6	5.0	Standard Deviation 4.43	score on a scale
Peak SOWS Scores at Baseline and Over Time	240 Micrograms	Baseline, Pre-Dose, Day 6	6.5	Standard Deviation 7.38	score on a scale
Peak SOWS Scores at Baseline and Over Time	Pooled Placebo	Baseline, Pre-Dose, Day 6	6.2	Standard Deviation 6.93	score on a scale
Peak SOWS Scores at Baseline and Over Time	30 Micrograms	Day 6 Post-dose	4.0	Standard Deviation 3.30	score on a scale
Peak SOWS Scores at Baseline and Over Time	60 Micrograms	Day 6 Post-dose	9.1	Standard Deviation 7.49	score on a scale
Peak SOWS Scores at Baseline and Over Time	90 Micrograms	Day 6 Post-dose	7.7	Standard Deviation 5.01	score on a scale

1 to 10 of 399Source ClinicalTrials.gov

See all 399 results by group

Participant flow42

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Opioid Maintenance Phase	STARTED	Morphine Maintenance, Then Cohort 1- 30 Micrograms	29
Opioid Maintenance Phase	STARTED	Morphine Maintenance, Then Cohort 2- 60 Micrograms	35
Opioid Maintenance Phase	STARTED	Morphine Maintenance, Then Cohort 3- 90 Micrograms	31
Opioid Maintenance Phase	STARTED	Morphine Maintenance, Then Cohort 4- 120 Micrograms	32
Opioid Maintenance Phase	STARTED	Morphine Maintenance, Then Cohort 5- 180 Micrograms	40
Opioid Maintenance Phase	STARTED	Morphine Maintenance, Then Cohort 6- 240 Micrograms	33
Opioid Maintenance Phase	STARTED	Morphine Maintenance, Then Cohort 7- Placebo	25
Opioid Maintenance Phase	COMPLETED	Morphine Maintenance, Then Cohort 1- 30 Micrograms	17
Opioid Maintenance Phase	COMPLETED	Morphine Maintenance, Then Cohort 2- 60 Micrograms	17
Opioid Maintenance Phase	COMPLETED	Morphine Maintenance, Then Cohort 3- 90 Micrograms	21

1 to 10 of 42Source ClinicalTrials.gov

See all 42 participant flow

Adverse events175

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Bradycardia	Cardiac disorders	30 Micrograms	0	17	0
other	Bradycardia	Cardiac disorders	60 Micrograms	0	17	0
other	Bradycardia	Cardiac disorders	90 Micrograms	0	21	0
other	Bradycardia	Cardiac disorders	120 Micrograms	0	19	0
other	Bradycardia	Cardiac disorders	180 Micrograms	0	21	0
other	Bradycardia	Cardiac disorders	240 Micrograms	1	15	1
other	Bradycardia	Cardiac disorders	Pooled Placebo	0	25	0
other	Lacrimation Increased	Eye disorders	30 Micrograms	0	17	0
other	Lacrimation Increased	Eye disorders	60 Micrograms	0	17	0
other	Lacrimation Increased	Eye disorders	90 Micrograms	0	21	0

1 to 10 of 175Source ClinicalTrials.gov

See all 175 adverse events

Adverse event totals21

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	30 Micrograms	0	17
Total, all-cause mortality	60 Micrograms	0	17
Total, all-cause mortality	90 Micrograms	0	21
Total, all-cause mortality	120 Micrograms	0	19
Total, all-cause mortality	180 Micrograms	0	21
Total, all-cause mortality	240 Micrograms	0	15
Total, all-cause mortality	Pooled Placebo	0	25
Total, other adverse events	30 Micrograms	1	17
Total, other adverse events	60 Micrograms	5	17
Total, other adverse events	90 Micrograms	2	21

1 to 10 of 21Source ClinicalTrials.gov

See all 21 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36630319	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04470050

GET https://conductscience.org/api/trials/v1/NCT04470050/results?page=2

API reference For AI assistants