MDMA-Assisted Psychotherapy in People With Posttraumatic Stress Disorder

• Sponsor: Multidisciplinary Association for Psychedelic Studies (Other)
• Overall Status: Completed
• CT.gov ID: NCT00090064
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arms: 2
• Duration (Months): 78
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This randomized, double-blind placebo-controlled study assessed the safety and effectiveness of MDMA-assisted therapy among people with chronic, treatment-resistant PTSD, including veterans. The study enrolled 23 participants. Participants were assigned to receive either therapy with a single divided dose of MDMA or lactose placebo during two blinded experimental sessions spaced three to five weeks apart during Stage 1 of the study. During these experimental sessions, participants received an initial dose of 125 mg of MDMA followed by a supplemental dose of 62.5 mg of MDMA, or they received initial and supplemental doses of inactive placebo.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder	Drug: 3,4-methylenedioxymethamphetamine; Drug: Lactose placebo pill; Behavioral: Therapy	Phase 2

Detailed Description

Posttraumatic stress disorder (PTSD) occurs in response to a traumatic event or events. It is most likely to occur following an event involving perceived personal threat, such as rape or physical assault. PTSD is clearly a public health problem that causes a great deal of suffering and accounts for a significant portion of health care costs.

MDMA is a substance possessing unique effects that make it well suited to intensive psychotherapy. MDMA has been hypothesized to represent a new class of drugs, called entactogens, that produce feelings of closeness to others, empathy, well being, and insightfulness. Anecdotal reports of therapy conducted before MDMA was placed on Schedule I suggest that MDMA-assisted psychotherapy may benefit people with PTSD.

This randomized, double-blind placebo-controlled study assessed the safety and effectiveness of MDMA-assisted therapy among people with chronic, treatment-resistant PTSD, including veterans. The study enrolled 23 participants. Participants were assigned to receive either therapy with a single divided dose of MDMA or lactose placebo during two blinded experimental sessions spaced three to five weeks apart during Stage 1 of the study. During these experimental sessions, participants received an initial dose of 125 mg of MDMA followed by a supplemental dose of 62.5 mg of MDMA, or they received initial and supplemental doses of inactive placebo. Psychotherapists and independent raters were blinded to participants' treatment conditions. This treatment period also consisted of preparatory sessions and several non-drug therapy sessions to facilitate integration of material arising during experimental sessions.

During Stage 2 of the study, the blind was broken and participants assigned to receive MDMA in Stage 1 underwent a third open-label experimental session of MDMA-assisted therapy. Participants assigned placebo during Stage 1 who chose to enroll in Stage 2 underwent three open-label sessions of MDMA-assisted therapy. Outcome measures were administered two months after the second MDMA or placebo session in Stage 1 and four to six weeks after the second MDMA session in Stage 2. A final data-collection session took place at two months after the third experimental session.

The primary objective of the study was to measure change in PTSD symptoms via CAPS-IV across the study in participants receiving the placebo vs. full dose of MDMA-assisted psychotherapy.

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase II Clinical Trial Testing the Safety and Efficacy of 3,4-Methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy in Subjects With Chronic Posttraumatic Stress Disorder
• Study Start Date: Mar 1, 2004
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MDMA-assisted therapy Participants will receive an initial dose of 125 mg MDMA orally followed 2 to 2.5 hours later by a second dose of 62.5 mg MDMA during two 8-hour long blinded therapy sessions.	Drug: 3,4-methylenedioxymethamphetamine; 125 mg MDMA followed by a supplemental half-dose of 62.5 mg MDMA; Other Names: MDMA ; Behavioral: Therapy; Non-directive therapy provided by a team of two co-therapists
Placebo Comparator: Placebo with therapy Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.	Drug: Lactose placebo pill; 125 mg placebo followed by a supplemental half-dose of 62.5 mg placebo; Other Names: Placebo ; Behavioral: Therapy; Non-directive therapy provided by a team of two co-therapists

Outcome Measures

Primary Outcome Measures

1. Baseline Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) [Less than 4 weeks before first experimental session]

   The CAPS-IV is a structured clinical interview designed to assess the symptoms and severity of PTSD. The CAPS-IV provides a means to evaluate the frequency and intensity dimensions of each symptom, the impact of symptoms on the patient's social and occupational functioning, the overall severity of the symptom complex, global improvement since baseline, and the validity of the ratings obtained. Total severity scores range from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.

2. Primary Endpoint Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) [2 months after second experimental session]

   The CAPS-IV is a structured clinical interview designed to assess the symptoms and severity of PTSD. The CAPS-IV provides a means to evaluate the frequency and intensity dimensions of each symptom, the impact of symptoms on the patient's social and occupational functioning, the overall severity of the symptom complex, global improvement since baseline, and the validity of the ratings obtained. Total severity scores range from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.

3. Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 2-month Follow-up [Baseline to 2 months post second experimental session]

   The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.

Secondary Outcome Measures

1. Baseline Impact of Events Scale Revised (IES-R) [Baseline (less than 4 weeks before first experimental session)]

   The Impact of Events Scale Revised (IES-R) is a 22-item self-report measure (for DSM-IV) designed to measure the extent to which a given stressful life event produces subjective distress. Each item corresponds directly to 14 of the 17 DSM-IV symptoms of PTSD and is rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely") for the extent to which the item was true for the participant during the past seven days. The IES-R yields a total score ranging from 0 to 88 with higher scores indicated greater distress.

2. Primary Endpoint Impact of Events Scale Revised (IES-R) [2 months after second experimental session]

   The Impact of Events Scale Revised (IES-R) is a 22-item self-report measure (for DSM-IV) designed to measure the extent to which a given stressful life event produces subjective distress. Each item corresponds directly to 14 of the 17 DSM-IV symptoms of PTSD and is rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely") for the extent to which the item was true for the participant during the past seven days. The IES-R yields a total score ranging from 0 to 88 with higher scores indicated greater distress.

3. Change in Impact of Events Scale Revised (IES-R) From Baseline to 2-month Follow-up [Baseline to 2 months post second experimental session]

   The Impact of Events Scale Revised (IES-R) is a 22-item self-report measure (for DSM-IV) designed to measure the extent to which a given stressful life event produces subjective distress. Each item corresponds directly to 14 of the 17 DSM-IV symptoms of PTSD and is rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely") for the extent to which the item was true for the participant during the past seven days. The IES-R yields a total score ranging from 0 to 88 with higher scores indicated greater distress.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Be diagnosed with chronic PTSD, duration of 5 years or longer resulting from traumatic experience during military service or a victim of crime;

• Have a CAPS score showing moderate to severe PTSD symptoms;

1. Have had at least one unsuccessful attempt at treatment for PTSD either with talk therapy or with drugs, or discontinuing treatment because of inability to tolerate psychotherapy or drug therapy.

2. Are at least 18 years old;

• Must be generally healthy;

• Must sign a medical release for the investigators to communicate directly with their therapist and doctors;

• Are willing to refrain from taking any psychiatric medications during the study period;

• Willing to follow restrictions and guidelines concerning consumption of food, beverages, and nicotine the night before and just prior to each experimental session;

• Willing to remain overnight at the study site;

• Agree to have transportation other than driving themselves home or to where they are staying after the integrative session on the day after the MDMA session;

• are willing to be contacted via telephone for all necessary telephone contacts;

• Must have a negative pregnancy test if able to bear children, and agree to use an effective form of birth control;

• must provide a contact in the event of a participant becoming suicidal;

• Are proficient in speaking and reading English;

• agree to have all clinic visit sessions recorded to audio and video

• Agree not to participate in any other interventional clinical trials during the duration of this study.

Exclusion Criteria:

• Are pregnant or nursing, or if a woman who can have children, those who are not practicing an effective means of birth control;

• Weigh less than 50 kg;

• Are abusing illegal drugs;

• Are unable to give adequate informed consent;

• Upon review of past and current drugs/medication must not be on or have taken a medication that is exclusionary.

• Upon review of medical or psychiatric history must not have any current or past diagnosis that would be considered a risk to participation in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Offices of Michael Mithoefer MD	Mount Pleasant	South Carolina	United States	29464

Sponsors and Collaborators

• Multidisciplinary Association for Psychedelic Studies

Investigators

• Principal Investigator: Michael Mithoefer, MD, Private Practice

Study Documents (Full-Text)

• Study Protocol - Jan 23, 2009
• Statistical Analysis Plan - Nov 9, 2011

More Information

Additional Information:

• View more information about MAPS' research into use of MDMA-assisted psychotherapy in people with PTSD

Publications

None provided.

• Responsible Party: Multidisciplinary Association for Psychedelic Studies
• ClinicalTrials.gov Identifier: NCT00090064
• Other Study ID Numbers: MP1
• First Posted: Aug 25, 2004
• Last Update Posted: Nov 26, 2021
• Last Verified: Nov 1, 2021

• Keywords provided by Multidisciplinary Association for Psychedelic Studies: MDMA; Methylenedioxymethamphetamine; PTSD; psychotherapy
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; N-Methyl-3,4-methylenedioxyamphetamine

Study Results

Participant Flow

Recruitment Details	Participants were recruited via letters to psychotherapists and internet advertisements.

Arm/Group Title	MDMA-assisted Therapy	Placebo With Therapy
Arm/Group Description	Participants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during two 8-hour long blinded therapy sessions.	Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.
Period Title: Overall Study
STARTED	15	8
COMPLETED	12	8
NOT COMPLETED	3	0

Baseline Characteristics

Arm/Group Title	MDMA-assisted Therapy	Placebo With Therapy	Total
Arm/Group Description	Participants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during two 8-hour long blinded therapy sessions.	Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.	Total of all reporting groups
Overall Participants	12	8	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.2 (7.6)	40.8 (7.0)	40.4 (7.2)
Sex: Female, Male (Count of Participants)
Female	10 83.3%	7 87.5%	17 85%
Male	2 16.7%	1 12.5%	3 15%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	12 100%	8 100%	20 100%
On disability for PTSD (Count of Participants)
Count of Participants [Participants]	2 16.7%	1 12.5%	3 15%
History of alcohol abuse/dependency (Count of Participants)
Count of Participants [Participants]	1 8.3%	1 12.5%	2 10%
History of other substance abuse/dependency (Count of Participants)
Count of Participants [Participants]	0 0%	1 12.5%	1 5%
Duration of PTSD (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	232 (201)	273 (126)	248 (173)
Comorbid major depression (Count of Participants)
Count of Participants [Participants]	9 75%	7 87.5%	16 80%
Comorbid anxiety disorder (Count of Participants)
Count of Participants [Participants]	2 16.7%	1 12.5%	3 15%
Prior therapy duration (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	40.6 (38.5)	85.3 (54.2)	58.5 (49.5)

Outcome Measures

1. Primary Outcome

Title	Baseline Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV)
Description	The CAPS-IV is a structured clinical interview designed to assess the symptoms and severity of PTSD. The CAPS-IV provides a means to evaluate the frequency and intensity dimensions of each symptom, the impact of symptoms on the patient's social and occupational functioning, the overall severity of the symptom complex, global improvement since baseline, and the validity of the ratings obtained. Total severity scores range from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Time Frame	Less than 4 weeks before first experimental session

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MDMA-assisted Therapy	Placebo With Therapy
Arm/Group Description	Participants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during two 8-hour long blinded therapy sessions.	Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.
Measure Participants	12	8
Mean (Standard Deviation) [score on a scale]	80.5 (21.73)	79.6 (21.97)

2. Primary Outcome

Title	Primary Endpoint Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV)
Description	The CAPS-IV is a structured clinical interview designed to assess the symptoms and severity of PTSD. The CAPS-IV provides a means to evaluate the frequency and intensity dimensions of each symptom, the impact of symptoms on the patient's social and occupational functioning, the overall severity of the symptom complex, global improvement since baseline, and the validity of the ratings obtained. Total severity scores range from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Time Frame	2 months after second experimental session

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MDMA-assisted Therapy	Placebo With Therapy
Arm/Group Description	Participants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during two 8-hour long blinded therapy sessions.	Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.
Measure Participants	12	8
Mean (Standard Deviation) [score on a scale]	25.3 (25.02)	59.1 (28.90)

3. Primary Outcome

Title	Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 2-month Follow-up
Description	The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Time Frame	Baseline to 2 months post second experimental session

Outcome Measure Data

Analysis Population Description

Intent-to-treat

Arm/Group Title	MDMA-assisted Therapy	Placebo With Therapy
Arm/Group Description	Participants will receive an initial dose of 125 mg MDMA orally followed 2 to 2.5 hours later by a second dose of 62.5 mg MDMA during two 8-hour long blinded therapy sessions. 3,4-methylenedioxymethamphetamine: 125 mg MDMA followed by a supplemental half-dose of 62.5 mg MDMA Therapy: Non-directive therapy provided by a team of two co-therapists	Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions. Lactose placebo pill: 125 mg placebo followed by a supplemental half-dose of 62.5 mg placebo Therapy: Non-directive therapy provided by a team of two co-therapists
Measure Participants	12	8
Mean (Standard Deviation) [score on a scale]	-55.2 (33.54)	-20.5 (20.47)

4. Secondary Outcome

Title	Baseline Impact of Events Scale Revised (IES-R)
Description	The Impact of Events Scale Revised (IES-R) is a 22-item self-report measure (for DSM-IV) designed to measure the extent to which a given stressful life event produces subjective distress. Each item corresponds directly to 14 of the 17 DSM-IV symptoms of PTSD and is rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely") for the extent to which the item was true for the participant during the past seven days. The IES-R yields a total score ranging from 0 to 88 with higher scores indicated greater distress.
Time Frame	Baseline (less than 4 weeks before first experimental session)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MDMA-assisted Therapy	Placebo With Therapy
Arm/Group Description	Participants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during two 8-hour long blinded therapy sessions.	Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.
Measure Participants	12	8
Mean (Standard Deviation) [score on a scale]	44.9 (16.77)	45.1 (11.84)

5. Secondary Outcome

Title	Primary Endpoint Impact of Events Scale Revised (IES-R)
Description	The Impact of Events Scale Revised (IES-R) is a 22-item self-report measure (for DSM-IV) designed to measure the extent to which a given stressful life event produces subjective distress. Each item corresponds directly to 14 of the 17 DSM-IV symptoms of PTSD and is rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely") for the extent to which the item was true for the participant during the past seven days. The IES-R yields a total score ranging from 0 to 88 with higher scores indicated greater distress.
Time Frame	2 months after second experimental session

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MDMA-assisted Therapy	Placebo With Therapy
Arm/Group Description	Participants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during two 8-hour long blinded therapy sessions.	Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.
Measure Participants	12	8
Mean (Standard Deviation) [score on a scale]	15.0 (15.82)	26.5 (16.28)

6. Secondary Outcome

Title	Change in Impact of Events Scale Revised (IES-R) From Baseline to 2-month Follow-up
Description	The Impact of Events Scale Revised (IES-R) is a 22-item self-report measure (for DSM-IV) designed to measure the extent to which a given stressful life event produces subjective distress. Each item corresponds directly to 14 of the 17 DSM-IV symptoms of PTSD and is rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely") for the extent to which the item was true for the participant during the past seven days. The IES-R yields a total score ranging from 0 to 88 with higher scores indicated greater distress.
Time Frame	Baseline to 2 months post second experimental session

Outcome Measure Data

Analysis Population Description

Intent-to-treat

Arm/Group Title	MDMA-assisted Therapy	Placebo With Therapy
Arm/Group Description	Participants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during two 8-hour long blinded therapy sessions.	Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.
Measure Participants	12	8
Mean (Standard Deviation) [score on a scale]	-29.9 (22.23)	-14.7 (15.58)

Adverse Events

Time Frame	From baseline to the end of Stage 2 (approximately 8 months)
Arm/Group Title	MDMA-assisted Therapy (Stage 1)		Placebo With Therapy (Stage 1)		MDMA-assisted Therapy (Stage 2)
Arm/Group Description	Participants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during two 8-hour long blinded therapy sessions.		Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.		Participants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during two 8-hour long blinded therapy sessions.
All Cause Mortality
	MDMA-assisted Therapy (Stage 1)		Placebo With Therapy (Stage 1)		MDMA-assisted Therapy (Stage 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/8 (0%)		0/7 (0%)
Serious Adverse Events
	MDMA-assisted Therapy (Stage 1)		Placebo With Therapy (Stage 1)		MDMA-assisted Therapy (Stage 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/15 (13.3%)		0/8 (0%)		0/7 (0%)
Musculoskeletal and connective tissue disorders
Clavicle fracture	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Nervous system disorders
Syncope	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	MDMA-assisted Therapy (Stage 1)		Placebo With Therapy (Stage 1)		MDMA-assisted Therapy (Stage 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/15 (93.3%)		6/8 (75%)		6/7 (85.7%)
Cardiac disorders
Sinus tachycardia	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Palpitations	0/15 (0%)		0/8 (0%)		1/7 (14.3%)
Eye disorders
Vision blurred	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Visual impairment	2/15 (13.3%)		1/8 (12.5%)		0/7 (0%)
Gastrointestinal disorders
Diarrhea	3/15 (20%)	4	1/8 (12.5%)	4	2/7 (28.6%)	4
Dyspepsia	1/15 (6.7%)		0/8 (0%)		1/7 (14.3%)
Nausea	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Oropharyngeal blistering	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Vomiting	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Abdominal pain upper	0/15 (0%)		1/8 (12.5%)		0/7 (0%)
Gastric ulcer	0/15 (0%)		0/8 (0%)		1/7 (14.3%)
General disorders
Asthenia	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Chills	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Fatigue	4/15 (26.7%)	6	1/8 (12.5%)	3	1/7 (14.3%)	3
Feeling hot	2/15 (13.3%)		0/8 (0%)		0/7 (0%)
Influenza like illness	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Irritability	2/15 (13.3%)		0/8 (0%)		0/7 (0%)
Pain	1/15 (6.7%)		1/8 (12.5%)		2/7 (28.6%)
Facial pain	0/15 (0%)		1/8 (12.5%)		0/7 (0%)
Infections and infestations
Laryngitis	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Pharyngitis streptococcal	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Sinusitis	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Upper respiratory tract infection	2/15 (13.3%)		1/8 (12.5%)		2/7 (28.6%)
Urinary tract infection	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Otitis media	0/15 (0%)		1/8 (12.5%)		0/7 (0%)
Pharyngitis	0/15 (0%)		1/8 (12.5%)		0/7 (0%)
Metabolism and nutrition disorders
Anorexia	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Musculoskeletal and connective tissue disorders
Back pain	1/15 (6.7%)		1/8 (12.5%)		0/7 (0%)
Muscle spasms	1/15 (6.7%)		1/8 (12.5%)		0/7 (0%)
Muscle strain	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Muscle tightness	5/15 (33.3%)		1/8 (12.5%)	2	1/7 (14.3%)	2
Musculoskeletal pain	2/15 (13.3%)		1/8 (12.5%)		1/7 (14.3%)
Neck pain	1/15 (6.7%)		1/8 (12.5%)		0/7 (0%)
Musculoskeletal chest pain	0/15 (0%)		2/8 (25%)	4	0/7 (0%)	4
Pain in extremity	0/15 (0%)		1/8 (12.5%)	2	1/7 (14.3%)	2
Arthralgia	0/15 (0%)		1/8 (12.5%)		0/7 (0%)
Myalgia	0/15 (0%)		0/8 (0%)		1/7 (14.3%)
Nervous system disorders
Burning sensation	1/15 (6.7%)		1/8 (12.5%)	2	1/7 (14.3%)	2
Dizziness	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Headache	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Hypoaesthesia facial	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Myoclonus	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Tension headache	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Sciatica	0/15 (0%)		1/8 (12.5%)		0/7 (0%)
Psychiatric disorders
Anxiety	2/15 (13.3%)		4/8 (50%)	6	3/7 (42.9%)	6
Bruxism	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Depressed mood	1/15 (6.7%)		1/8 (12.5%)	2	0/7 (0%)	2
Derealisation	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Dissociation	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Disturbance in attention	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Major depression	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Panic attack	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Insomnia	0/15 (0%)		1/8 (12.5%)		0/7 (0%)
Memory impairment	0/15 (0%)		1/8 (12.5%)		0/7 (0%)
Agitation	0/15 (0%)		0/8 (0%)		1/7 (14.3%)
Flashback	0/15 (0%)		0/8 (0%)		1/7 (14.3%)
Renal and urinary disorders
Dysuria	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Nocturia	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Reproductive system and breast disorders
Ovarian cyst	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Sinus headache	1/15 (6.7%)		0/8 (0%)		0/7 (0%)
Throat tightness	0/15 (0%)		1/8 (12.5%)		0/7 (0%)
Skin and subcutaneous tissue disorders
Pruritus	0/15 (0%)		1/8 (12.5%)		0/7 (0%)
Dermatitis	0/15 (0%)		0/8 (0%)		1/7 (14.3%)
Surgical and medical procedures
Foot operation	1/15 (6.7%)		0/8 (0%)		0/7 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.