Effectiveness Study of Dronabinol and BRENDA for the Treatment of Cannabis Withdrawal

NCT00480441 | Completed Phase 2 Results DMC

• 1 other identifier: 5P60DA005186-19
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

This treatment study is targeted specifically for those who want to stop using marijuana. We want to find out if patients who are dependent on marijuana and want to stop using are helped by a combination of the drug dronabinol and six sessions of individual therapy (BRENDA). Dronabinol is a pill form of the active ingredient in marijuana (THC). Currently, dronabinol is approved for the treatment of nausea in people receiving cancer chemotherapy and as an appetite stimulant in people with AIDS. In some studies, dronabinol reduced the amount of psychological and physical discomfort experienced when people stopped using marijuana. One purpose of our study is to see if people who are on dronabinol have fewer problems with psychological and physical discomfort than those who are on a placebo. In addition to treatment, this research trial will also be measuring the reactions of subjects to drug-related cues, and also to computer-presented tasks unrelated to drug use. We may examine whether the response to these cues/tasks either predicts treatment outcome, or is affected by your treatment. This information may also help us to understand the ways in which chronic drug use causes changes in our subjects' mental functioning and how those changes respond to treatment. In addition to participation in the treatment research trial, some subjects may be asked to undergo a brain scan in an MRI. The purpose of the brain scan research project is to measure brain reactions with a non-invasive, non-radioactive imaging technique known as fMRI (functional magnetic resonance imaging) in marijuana subjects before and after treatment with the medication dronabinol or with an inactive substance (placebo).

Conditions

Marijuana Dependence

Keywords

Marijuana; Addiction; Substance Withdrawal Syndrome; Clinical Trial; Dronabinol; Behavioral Therapy; Adults; Neuroimaging; Neuropsychological Testing; Neurocognitive Testing; Behavioral Probes

Outcome Measures

Primary Outcomes (2)

• Physiological Changes in Response to Cue-induced Craving.

  Functional MRI brain response to cannabis vs neutral cues. Higher T values represent increased blood flow in response to cues.

  Baseline functional mri (fMRI), (prior to randomization)

• Tolerability of Treatment

  Reports of side effects leading to discontinuation of treatment were examined in all participants.

  baseline to two years

Study Arms (2)

1

ACTIVE COMPARATOR

Dronabinol+ BRENDA therapy

Drug: Dronabinol; Behavioral: BRENDA therapy

2

PLACEBO COMPARATOR

Placebo+BRENDA therapy

Behavioral: BRENDA therapy; Drug: Placebo

Interventions

Dronabinol DRUG

10mg capsules taken 4 times daily for 2 weeks and then tapered over 1 week

Also known as: Marinol

1

BRENDA therapy BEHAVIORAL

weekly therapy sessions for 6 weeks

1; 2

Placebo DRUG

4 capsules daily for 2 weeks followed by a 1 week taper

2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females, 18-55 years old
• Meets DSM-IV criteria for Cannabis Dependence
• History of chronic cannabis use of moderate intensity defined by 10 or more years of use with an average frequency of 2 or more joints/day on 5 or more days/week
• Live within a commutable distance of the Treatment Research Center
• Understand and sign the informed consent
• Voluntarily seeking treatment for cannabis dependence

You may not qualify if:

• Current DSM-IV diagnosis of any psychoactive substance dependence other than marijuana, or nicotine dependence
• Concomitant treatment with sedative hypnotics, opioid analgesics or other known CNS depressants at a dose and frequency that is unacceptable to the principal investigator
• Mandated to treatment based upon a legal decision or as a condition of employment
• Current severe psychiatric symptoms, e.g. psychosis, dementia, acute suicidal or homicidal ideation, mania or depression requiring antidepressant therapy, or which could make it unsafe for the patient to participate in the opinion of the primary investigators
• History of significant, unstable heart disease, including myocardial infarction, unstable angina, cardiac failure, second or third degree heart block, uncontrolled hypertension, syncope
• Known hypersensitivity to cannabinoids or sesame oil
• Any serious medical illness, which may require hospitalization during the study (i.e. sickle cell anemia, rheumatoid arthritis)
• Has any disease of the gastrointestinal system, liver or kidneys which could result in altered metabolism or excretion of the study medication (history of major gastrointestinal tract surgery, gastrectomy, gastrotomy, bowel resection, etc.) or history of chronic gastrointestinal disorders (ulcerative colitis, regional enteritis, or gastrointestinal bleeding)
• Female subjects who are pregnant or lactating, or female subjects of child bearing potential who are not using acceptable methods of birth control. Acceptable methods of birth control include:
• Barrier (diaphragm or condom) with spermicide, Intrauterine device, Levonorgestrel implant, Medroxyprogesterone acetate contraceptive injection, Oral contraceptives.
• Clinical laboratory tests (CBC, blood chemistries, urinalysis) outside normal limits that are clinically unacceptable to the principal investigators. On EKG, 1st degree heart block, sinus tachycardia, left axis deviation, and nonspecific ST or T wave changes are allowed. Liver function tests (LFT's) \<5 times ULN without symptoms of liver disease are acceptable after thorough medical review.
• Participation in a clinical trial and receipt of investigational drug(s) other than this clinical trial during previous 60 days.
• History of serious head trauma or injury causing loss of consciousness that lasted more than 3 minutes.
• Presence of magnetically active prosthetics, plates, pins, broken needles, permanent retainer, bullets, etc. in subject's body (unless a radiologist confirms that its presence is unproblematic). An X-ray may be obtained to determine eligibility.
• Claustrophobia or other medical condition disabling subject from laying in the MRI for approximately 60 minutes

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Treatment Research Center at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• Haney M, Hart CL, Vosburg SK, Nasser J, Bennett A, Zubaran C, Foltin RW. Marijuana withdrawal in humans: effects of oral THC or divalproex. Neuropsychopharmacology. 2004 Jan;29(1):158-70. doi: 10.1038/sj.npp.1300310.

  PMID: 14560320 BACKGROUND

• Goldman M, Szucs-Reed RP, Jagannathan K, Ehrman RN, Wang Z, Li Y, Suh JJ, Kampman K, O'Brien CP, Childress AR, Franklin TR. Reward-related brain response and craving correlates of marijuana cue exposure: a preliminary study in treatment-seeking marijuana-dependent subjects. J Addict Med. 2013 Jan-Feb;7(1):8-16. doi: 10.1097/ADM.0b013e318273863a.

  PMID: 23188041 DERIVED

MeSH Terms

Conditions

Marijuana Abuse; Behavior, Addictive; Substance Withdrawal Syndrome

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Marina Goldman, Principle Study Investigator
• Organization: Treatment Research Center

marinag@mail.med.upenn.edu

215 222 3200

Study Officials

• Charles O'Brien, M.D./Ph.D.

  Treatment Research Center at the University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2007
• First Posted: May 31, 2007
• Study Start: August 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 29, 2019
• Results First Posted: July 29, 2019

Record last verified: 2019-07

Locations

US (1)