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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:
ClinicalTrials.gov Identifier:
NCT00252174
First Posted: November 11, 2005
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Mclean Hospital
Information provided by (Responsible Party):
John H. Halpern, MD, Mclean Hospital
  Purpose
This is a pilot study intended to find out if 3,4-methylenedioxymethamphetamine (MDMA) is safe and can help people with advanced stage cancer and anxiety arising from the cancer diagnosis.

Condition Intervention Phase
Anxiety Disorder Cancer Drug: Stage 1 Active Methylenedioxymethamphetamine Drug: Stage 1 Low dose Methylenedioxymethamphetamine Behavioral: Psychotherapy Drug: Stage 2 Active Methylenedioxymethamphetamine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase II Dose-response Pilot Study of 3,4-methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy in Subjects With Anxiety Associated With Advanced-stage Cancer.

Resource links provided by NLM:


Further study details as provided by John H. Halpern, MD, Mclean Hospital:

Primary Outcome Measures:
  • Spielberger State-Trait Anxiety Inventory (STAI) [ Time Frame: Obtained over the 3 months of active participation ]
    Established self-report measure of anxiety containing a State and Trait subscale and scored on a four-point Likert scale. Scores for each subscale range from 10 to 40 and combined from 20 to 80 with higher scores indicative of greater anxiety.

  • 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 ]
    Self-report instrument assessing quality of life with five functional scales, and nine symptom scales. Higher functional scores indicate better quality of life and higher symptom scores indicate poorer quality of life. Scales include "Yes" / "No" responses and four-point Likert scales, with transformations performed on scores so that all scale scores range from 0 to 100.


Secondary Outcome Measures:
  • Anxiety - Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: Obtained over the 3 months of active participation ]
    standardized assessment of anxiety

  • 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 ]
    paper pencil tests capturing data on spiritual well-being, overall functioning living with cancer, psychiatric mental status, and on spiritual self-perception.

  • Hamilton Depression Rating Scale (HAM-D) [ Time Frame: Obtained over the 3 months of active participation ]
    Standardized interview assessing of depression, with higher scores indicative of greater depression. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.

  • Depression, Thoughts of Death - Schedule of Attitudes Toward Hastened Death (SAHD) [ Time Frame: Obtained over the 3 months of active participation ]
    standardized questions to evaluate extent of depression and thoughts of death.

  • Daily Use of Anxiolytics - Daily Diary [ Time Frame: Obtained over the 3 months of active participation ]
    daily log of anxiolytic medication usage.

  • Daily Experience of Pain - Visual Analog Pain Scale (VAPS) [ Time Frame: Obtained over the 3 months of active participation ]
    daily measure of self-reported pain.

  • The Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Obtained over the 3 months of active participation ]
    Standardized assessment of anxiety and depression consisting of a 7-item anxiety scale and a 7-item depression scale. Each scale score ranges from 0 to 21, with 0-7 being "normal" and 11-21 being "abnormal" [e.g. severely depressed or anxious]

  • Daily Assessment of Anxiety - the Visual Analog Anxiety Scale (VAAS) [ Time Frame: Obtained over the 3 months of active participation ]
    Daily self-report measure for anxiety.

  • Beck Hopelessness Scale (BHI) [ Time Frame: Obtained over 3 months of study ]
    Established self-report measure of depression and hopelessness, consisting of 20 true-false questions, with scores ranging from 0 to 20, with scores of 0-3 indicating minimal hopelessness and scores of 15-20 severe hopelessness.


Enrollment: 2
Study Start Date: February 2007
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stage 1 Active methylenedioxymethamphetamine & psychotherapy
8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.
Drug: Stage 1 Active Methylenedioxymethamphetamine

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.

Behavioral: Psychotherapy
Psychotherapy conducted with low or active dose MDMA
Active Comparator: Stage 1 low dose methylenedioxymethamphetamine & Psychotherapy
4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I
Drug: Stage 1 Low dose Methylenedioxymethamphetamine

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.

Behavioral: Psychotherapy
Psychotherapy conducted with low or active dose MDMA
Experimental: Stage 2 Active methylenedioxymethamphetamine & Psychotherapy
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.
Behavioral: Psychotherapy
Psychotherapy conducted with low or active dose MDMA
Drug: Stage 2 Active Methylenedioxymethamphetamine

Administered open label 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.


  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis with advanced-stage cancer (usually meaning inoperable or incurable) with a life expectancy of less than 12 months.
  • Anxiety as a result of cancer diagnosis
  • Failure to respond adequately or at all to medication intended to reduce anxiety, or have refused to take anxiolytic medication.
  • Completed or independently decided to end all direct cancer treatments, such as chemotherapy and radiation, two weeks prior to the first experimental (MDMA) session. If subjects wish to initiate or resume treatment for cancer at any point prior to the second experimental (MDMA) session, then they will be withdrawn from the study and will be asked to see the co-investigator oncologist for a final physical examination. Participants will not be withdrawn from the study if they initiate or resume treatment after the second experimental (MDMA) session. Those who are receiving cycles of cancer treatments for only palliative purposes (no longer for any curative reasons or to induce complete remission), may also be included in this study provided that they, as well, have completed their last cycle of treatment at least two weeks prior to the first experimental (MDMA) session and provided that they will not resume another cycle of treatment until after completion of the second experimental (MDMA) session. If a subject receiving palliative cancer treatment decides to receive a next cycle of this cancer treatment prior to the second experimental session, then, again, they will be withdrawn from the study. Participants will not be withdrawn from the study if they initiate or resume palliative cancer treatments after the second experimental (MDMA) session.
  • Willing to commit to and follow all directions and restrictions relating to the study period
  • Must be willing and able to discontinue use of psychiatric medication except that being used to treat anxiety. If still taking medication when enrolled to the study, medication will be discontinued long enough before the first MDMA-assisted psychotherapy session to avoid a drug-drug interaction
  • Must be willing and able to stay overnight at the facility after each MDMA-assisted session.
  • If seeing another psychotherapist, participants must be willing to give the principal investigator permission to communicate with him or her.
  • Female participants of childbearing potential must have a negative pregnancy test and must agree to use an effective form of birth control.

Exclusion Criteria:

  • People with a life expectancy of longer than 12 months
  • Women who are pregnant or nursing, or of child bearing potential and are not practicing an effective means of birth control.
  • People with any dissociative disorder, anorexia nervosa, bulimia nervosa, a primary psychotic disorder or affective disorder other than anxiety related to advanced stage cancer
  • People diagnosed with abuse of or dependence on any substance (other than caffeine or nicotine) in the past 60 days.
  • People with known primary or metastatic cancer of the CNS
  • People with significant, unstable hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder, that in the clinical judgment of the investigators poses too great a potential for side-effects.
  • People with significant peripheral vascular disease, hepatic disease, renal insufficiency, or preexisting or past evidence of hyponatremia.
  • People diagnosed with hypertension, even if well-controlled with medication. A systolic blood pressure of 140 or greater and/or a diastolic blood pressure of 90 or greater will exclude the potential participant from this study.
  • People with liver enzyme values indicative of severely compromised hepatic (liver) function
  • People who weigh less than 45 kg (98 lb)
  • People reporting a history of use of "ecstasy" (illicit drug preparations purported to contain MDMA) at any time within the previous 3 months.
  • People reasonably judged to present a serious suicide risk or who are likely to require psychiatric hospitalization during the course of the study
  • People requiring psychotropic medication other than anxiolytic medication or for pain control
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00252174


Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478-9106
Sponsors and Collaborators
Brigham and Women's Hospital
Mclean Hospital
Investigators
Principal Investigator: John H Halpern, MD Mclean Hospital
  More Information

Responsible Party: John H. Halpern, MD, Director, Laboratory for Integrative Psychiatry, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00252174     History of Changes
Other Study ID Numbers: 76,770
First Submitted: November 9, 2005
First Posted: November 11, 2005
Results First Submitted: January 20, 2017
Results First Posted: May 5, 2017
Last Update Posted: November 14, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by John H. Halpern, MD, Mclean Hospital:
MDMA
cancer
anxiety
psychotherapy
quality of life

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
N-Methyl-3,4-methylenedioxyamphetamine
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents