MDMA-assisted Therapy in People With Anxiety Related to Advanced Stage Cancer

This study has been terminated.

(Lack of funds and insufficient patient population for study enrollment.)

Sponsor:

Collaborator:

Mclean Hospital

Information provided by (Responsible Party):

John H. Halpern, MD, Mclean Hospital

ClinicalTrials.gov Identifier:

NCT00252174

First received: November 9, 2005

Last updated: March 27, 2017

Last verified: March 2017

History of Changes

Results First Received: January 20, 2017

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
Conditions:	Anxiety Disorder Cancer
Interventions:	Drug: Stage 1 Active Methylenedioxymethamphetamine Drug: Stage 1 Low dose Methylenedioxymethamphetamine Behavioral: Psychotherapy Drug: Stage 2 Active Methylenedioxymethamphetamine

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

Description

Stage 1, Active

8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.

3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule

Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):

Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.

Stage 1, Control

4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I

3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule

Dosage frequency and duration for the control arm (4 subjects):

Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg.

Stage 2, Active

The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.

3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule

Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):

Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.

Participant Flow: Overall Study

	Stage 1, Active	Stage 1, Control	Stage 2, Active
STARTED	0 ^[1]	2 ^[2]	0 ^[3]
COMPLETED	0	1	0
NOT COMPLETED	0	1	0
Withdrawal by Subject	0	1	0

^[1]	No subjects were randomized into Active Arm as only 2 subjects were randomized into the Control Arm.
^[2]	2 subjects entered the control arm in total
^[3]	No subjects entered Stage 2

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Stage 1, Active	8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.
Stage 1, Control	4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I 3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule Dosage frequency and duration for the control arm (4 subjects): Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg.
Stage 2, Active	The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength. 3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2): Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg.
Total	Total of all reporting groups

Baseline Measures

	Stage 1, Active	Stage 1, Control	Stage 2, Active	Total
Overall Participants Analyzed [Units: Participants]	0	2	0	2

Age [Units: Participants] Count of Participants
<=18 years		0 0.0%		0 0.0%
Between 18 and 65 years		0 0.0%		0 0.0%
>=65 years		2 100.0%		2 100.0%

Age [Units: Years] Mean (Full Range)		66 (65 to 67)		66 (65 to 67)

Sex: Female, Male [Units: Participants] Count of Participants
Female		0 0.0%		0 0.0%
Male		2 100.0%		2 100.0%

Ethnicity (NIH/OMB) [Units: Participants] Count of Participants
Hispanic or Latino		0 0.0%		0 0.0%
Not Hispanic or Latino		2 100.0%		2 100.0%
Unknown or Not Reported		0 0.0%		0 0.0%

Race (NIH/OMB) [Units: Participants] Count of Participants
American Indian or Alaska Native		0 0.0%		0 0.0%
Asian		0 0.0%		0 0.0%
Native Hawaiian or Other Pacific Islander		0 0.0%		0 0.0%
Black or African American		0 0.0%		0 0.0%
White		2 100.0%		2 100.0%
More than one race		0 0.0%		0 0.0%
Unknown or Not Reported		0 0.0%		0 0.0%

Region of Enrollment [Units: Participants]
United States		2		2

Outcome Measures

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1. Primary:

Spielberger State-Trait Anxiety Inventory (STAI) [ Time Frame: Obtained over the 3 months of active participation ]

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2. Primary:

Quality of Life - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) [ Time Frame: Obtained over the 3 months of active participation ]

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3. Secondary:

Anxiety - Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: Obtained over the 3 months of active participation ]

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4. Secondary:

Quality of Life - Functional Assessment of Chronic Illness Therapy- Spiritual Well-being Scale (FACIT-Sp),Karnofsky Performance Rating Scale (KPRS), Memorial Symptom Assessment Scale (MSAS), Mini-Mental Status Exam (MMSE), Self-Expansiveness Level Form [ Time Frame: Obtained over the 3 months of active participation ]

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5. Secondary:

Hamilton Depression Rating Scale (HAM-D) [ Time Frame: Obtained over the 3 months of active participation ]

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6. Secondary:

Depression, Thoughts of Death - Schedule of Attitudes Toward Hastened Death (SAHD) [ Time Frame: Obtained over the 3 months of active participation ]

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7. Secondary:

Daily Use of Anxiolytics - Daily Diary [ Time Frame: Obtained over the 3 months of active participation ]

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8. Secondary:

Daily Experience of Pain - Visual Analog Pain Scale (VAPS) [ Time Frame: Obtained over the 3 months of active participation ]

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9. Secondary:

The Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Obtained over the 3 months of active participation ]

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10. Secondary:

Daily Assessment of Anxiety - the Visual Analog Anxiety Scale (VAAS) [ Time Frame: Obtained over the 3 months of active participation ]

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11. Secondary:

Beck Hopelessness Scale (BHI) [ Time Frame: Obtained over 3 months of study ]

Results not yet reported. Anticipated Reporting Date: No text entered.

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

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

Results Point of Contact:

Name/Title: John H. Halpern, M.D.
Organization: McLean Hospital at time of study
phone: 6179065063
e-mail: jhalpern@recoverycoa.com

Responsible Party:	John H. Halpern, MD, Mclean Hospital
ClinicalTrials.gov Identifier:	NCT00252174 History of Changes
Other Study ID Numbers:	76,770
Study First Received:	November 9, 2005
Results First Received:	January 20, 2017
Last Updated:	March 27, 2017

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