Trial · NCT03538054

Dextromethorphan in Fibromyalgia

NCT03538054, Phase 2, Completed, University of Alabama at Birmingham; results first posted 2022-08-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Dextromethorphan in Fibromyalgia. Trials, record NCT03538054. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03538054

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Trial

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

Title: Dextromethorphan in Fibromyalgia
NCT number: NCT03538054
Status: Completed
Phases: Phase 2
Enrollment: 27 participants, actual
Lead sponsor: University of Alabama at Birmingham
Conditions: Fibromyalgia
Interventions: Dextromethorphan, Placebo
First posted: 2018-05-25
Last updated: 2022-08-26
Results first posted: 2022-08-26
Limitations and caveats: Medication was tested in a small number of fibromyalgia (FM) patients, limiting generalizability. Length of DXM treatment was only 10 weeks, so it is unclear if the results are durable. We used a single-blind design that could have led to experimenter bias. We relied only on self-reported pain rather than using objective pain assessments.

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Daily Self-reported Pain Severity	Daily over 4 weeks	Daily self-reported widespread pain severity, rated on a 0 - 100 scale (0 = no pain and 100 = worst pain possible). Participants' daily scores from the last 4 weeks of each condition (placebo and dextromethorphan) were summed and then averaged across the 4-week time period.
Secondary	Daily Self-reported Physical Activity	Daily over 4 weeks	Self-reported daily activity, rated from 0 - 100 where 0 is less daily activity and 100 is the most amount of daily activity. Participants' daily scores from the last 4 weeks of each condition (placebo and dextromethorphan) were summed and then averaged across the 4-week time period.
Secondary	Patient Global Impression of Change	20 weeks	Patient global impression of change (PGIC) measured on a seven point likert scale (1 = "no change" to 7 = "a great deal better"). PGIC's were not administered to participants. The PGIC was inadvertently left out of the lab visit packet. Since the PGIC was not administered, data was not collected for both arms/groups.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Daily Self-reported Pain Severity	Daily over 4 weeks	All 14 participants underwent both the Dextromethorphan and Placebo conditions (within-subjects comparisons).	score/day	MEAN
SECONDARY	Daily Self-reported Physical Activity	Daily over 4 weeks	All 14 participants underwent both the Dextromethorphan and Placebo conditions (within-subjects comparisons).	score/day	MEAN
SECONDARY	Patient Global Impression of Change	20 weeks	Scores for the PGIC secondary outcome were not available for analyses due to administrator error. PGIC's were not administered to participants. The PGIC was inadvertently left out of the lab visit packet. Since the PGIC was not administered, data was not collected for both arms/groups.

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
Daily Self-reported Pain Severity	Dextromethorphan	41.09	Standard Deviation 24.32	score/day
Daily Self-reported Pain Severity	Placebo	45.55	Standard Deviation 24.69	score/day
Daily Self-reported Physical Activity	Dextromethorphan	46.92	Standard Deviation 19.79	score/day
Daily Self-reported Physical Activity	Placebo	50.10	Standard Deviation 19.70	score/day

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Baseline Phase (2 Weeks)	STARTED	Placebo First, Then Dextromethorphan	19
Baseline Phase (2 Weeks)	COMPLETED	Placebo First, Then Dextromethorphan	18
Baseline Phase (2 Weeks)	NOT COMPLETED	Placebo First, Then Dextromethorphan	1
Placebo Phase (5 Weeks)	STARTED	Placebo First, Then Dextromethorphan	18
Placebo Phase (5 Weeks)	COMPLETED	Placebo First, Then Dextromethorphan	16
Placebo Phase (5 Weeks)	NOT COMPLETED	Placebo First, Then Dextromethorphan	2
Dextromethorphan Phase (10 Weeks)	STARTED	Placebo First, Then Dextromethorphan	16
Dextromethorphan Phase (10 Weeks)	COMPLETED	Placebo First, Then Dextromethorphan	14
Dextromethorphan Phase (10 Weeks)	NOT COMPLETED	Placebo First, Then Dextromethorphan	2

Source ClinicalTrials.gov

Adverse events48

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	Anxiety	Nervous system disorders	Placebo	0	14	0
other	Anxiety	Nervous system disorders	Dextromethorphan	2	14	2
other	Bloating	Gastrointestinal disorders	Placebo	1	14	1
other	Bloating	Gastrointestinal disorders	Dextromethorphan	1	14	1
other	Chest tightness	Respiratory, thoracic and mediastinal disorders	Placebo	0	14	0
other	Chest tightness	Respiratory, thoracic and mediastinal disorders	Dextromethorphan	1	14	1
other	Cold/respiratory infection	Respiratory, thoracic and mediastinal disorders	Placebo	1	14	1
other	Cold/respiratory infection	Respiratory, thoracic and mediastinal disorders	Dextromethorphan	0	14	0
other	Constipation	Gastrointestinal disorders	Placebo	0	14	0
other	Constipation	Gastrointestinal disorders	Dextromethorphan	2	14	2

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	14
Total, all-cause mortality	Dextromethorphan	0	14
Total, other adverse events	Placebo	7	14
Total, other adverse events	Dextromethorphan	11	14
Total, serious adverse events	Placebo	0	14
Total, serious adverse events	Dextromethorphan	0	14

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons2

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

Comparison	Source
Dextromethorphan vs Placebo: deaths from any cause	Trial comparisons
Dextromethorphan vs Placebo: serious adverse events	Trial comparisons

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/NCT03538054

GET https://conductscience.org/api/trials/v1/NCT03538054/events?page=2

API reference For AI assistants