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

NCT00252174 | Terminated Phase 2 Results DMC

• 1 other identifier: 76,770
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety Disorder; Cancer

Keywords

MDMA; cancer; anxiety; psychotherapy; quality of life

Outcome Measures

Primary Outcomes (2)

• Spielberger State-Trait Anxiety Inventory (STAI)

  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.

  Obtained over the 3 months of active participation

• Quality of Life - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

  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.

  Obtained over the 3 months of active participation

Secondary Outcomes (9)

• Anxiety - Hamilton Anxiety Rating Scale (HAM-A)

  Obtained over the 3 months of active participation

• 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

  Obtained over the 3 months of active participation

• Hamilton Depression Rating Scale (HAM-D)

  Obtained over the 3 months of active participation

• Depression, Thoughts of Death - Schedule of Attitudes Toward Hastened Death (SAHD)

  Obtained over the 3 months of active participation

• Daily Use of Anxiolytics - Daily Diary

  Obtained over the 3 months of active participation

Study Arms (3)

Stage 1 Active methylenedioxymethamphetamine & psychotherapy

EXPERIMENTAL

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; Behavioral: Psychotherapy

Stage 1 low dose methylenedioxymethamphetamine & Psychotherapy

ACTIVE COMPARATOR

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

Drug: Stage 1 Low dose Methylenedioxymethamphetamine; Behavioral: Psychotherapy

Stage 2 Active methylenedioxymethamphetamine & Psychotherapy

EXPERIMENTAL

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; Drug: Stage 2 Active Methylenedioxymethamphetamine

Interventions

Stage 1 Active Methylenedioxymethamphetamine DRUG

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 Active methylenedioxymethamphetamine & psychotherapy

Stage 1 Low dose Methylenedioxymethamphetamine DRUG

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 1 low dose methylenedioxymethamphetamine & Psychotherapy

Psychotherapy BEHAVIORAL

Psychotherapy conducted with low or active dose MDMA

Stage 1 Active methylenedioxymethamphetamine & psychotherapy; Stage 1 low dose methylenedioxymethamphetamine & Psychotherapy; Stage 2 Active methylenedioxymethamphetamine & Psychotherapy

Stage 2 Active Methylenedioxymethamphetamine DRUG

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.

Stage 2 Active methylenedioxymethamphetamine & Psychotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Mclean Hospital: collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478-9106, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Neoplasms

Interventions

N-Methyl-3,4-methylenedioxyamphetamine; Psychotherapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Behavioral Disciplines and Activities

Results Point of Contact

• Title: John H. Halpern, M.D.
• Organization: McLean Hospital at time of study

jhalpern@recoverycoa.com

6179065063

Study Officials

• John H Halpern, MD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Laboratory for Integrative Psychiatry

Study Record Dates

• First Submitted: November 9, 2005
• First Posted: November 11, 2005
• Study Start: February 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: November 14, 2017
• Results First Posted: May 5, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)