Prescription Drugs For...Marijuana Dependency

I came across this and couldn't believe what I was reading. They want to recruit stoners for controlled experiments to see if this PRESCRIPTION DRUG Lofexidine in combination with Marinol is better than a placebo in

"achieving abstinence, reducing cannabis use and reducing withdrawal in cannabis-dependent patients seeking treatment for their marijuana use"

If you read through this you might be as shocked as I was at what they are saying. It makes it seem like pot has withdrawal symptoms like that of heroin! I haven't seen ANY proof that cannabis is additive physically and you have physical withdrawals from it. 

Take a look... perhaps you'd like to volunteer. I'm sure they pay isn't shabby but then again it is by a University and they all interconnected with big corporate interests. 

Combined Pharmacotherapy for Cannabis Dependency (D-LUCS)

This study is currently recruiting participants.

Verified October 2013 by New York State Psychiatric Institute

Sponsor:

New York State Psychiatric Institute

Collaborator:

National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

New York State Psychiatric Institute

ClinicalTrials.gov Identifier:

NCT01020019

First received: November 24, 2009

Last updated: October 29, 2013

Last verified: October 2013

History of Changes

  Purpose

The purpose of this study is to see if Lofexidine in combination with Marinol is superior to placebo in achieving abstinence, reducing cannabis use and reducing withdrawal in cannabis-dependent patients seeking treatment for their marijuana use.

 

ConditionInterventionPhase

Cannabis Dependence
Marijuana Dependence
Drug: Lofexidine and Dronabinol
Drug: Placebo
Phase 2
Phase 3

 

Study Type:Interventional

Study Design:Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Official Title:A Randomized, Double-Blind, Placebo-Controlled Study of Lofexidine and Dronabinol for the Treatment of Marijuana Dependence

 

Resource links provided by NLM:

 

MedlinePlus related topics: Marijuana

Drug Information available for: Dronabinol

U.S. FDA Resources 

Further study details as provided by New York State Psychiatric Institute:


Primary Outcome Measures:

  • Reduction in self reported days of marijuana use as measured by the Time-line Followback. [ Time Frame: reported daily for 12 weeks/ or study participation ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

  • Marijuana withdrawal as measured by the MWC-10 item [ Time Frame: reported 2x/week for 12 weeks/ or study participation ] [ Designated as safety issue: No ]

 

Estimated Enrollment:180

Study Start Date:January 2010

Estimated Study Completion Date:August 2014

Estimated Primary Completion Date:August 2014 (Final data collection date for primary outcome measure)

ArmsAssigned Interventions

Experimental: Lofexidine and Dronabinol

Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol

Drug: Lofexidine and Dronabinol

Lofex: .6 mg/ TID Dronabinol: 20 mg/TID

Other Name: Marinol

Placebo Comparator: Placebo

Lofex. matched placebo Dronabinol placebo

Drug: Placebo

Placebo control

Other Name: Placebo


Detailed Description:

Cannabis use disorders remain the most common illicit drug use disorder and options for treatment remain limited. Compared to other abusable substances, there has been little investigation of pharmacotherapies for cannabis dependence and no effective pharmacotherapy for cannabis dependence has yet to been developed. The development of effective cannabis dependence pharmacotherapy is an important unmet public health need. Agonist pharmacotherapy strategies have been effective for other substance use disorders (e.g., opioid and nicotine use disorders) and the endocannabinoid system represents a promising target for agonist pharmacotherapy with dronabinol. Lofexidine, a noradrenergic system suppressant, is effective in treating opioid withdrawal and shows promise as a cannabis use disorder pharmacotherapy. Haney et al. (2008) found that the combination of lofexidine and dronabinol (Lofex-Dro) was superior to placebo, lofexidine alone, or dronabinol alone in improving sleep and other cannabis withdrawal symptoms. Further, reduction in craving and relapse was greater for this combined pharmacotherapy relative to either medication alone or placebo. The proposed protocol is a 2 group, double blind, placebo-controlled outpatient study of the safety and efficacy of the combination of dronabinol and lofexidine for the treatment of cannabis dependence. We plan to enroll 180 subjects in a 12-week trial. The primary hypothesis is that dronabinol will act as an agonist treatment while lofexidine will suppress craving- and cue-induced related stress such that the combination will act in a complementary manner to induce prolonged abstinence from marijuana.

  Eligibility

Ages Eligible for Study:  18 Years to 60 Years

Genders Eligible for Study:  Both

Accepts Healthy Volunteers:  No

Criteria

Inclusion Criteria:

  1. Men and women between the ages of 18-60 who meet DSM-IV criteria for current marijuana dependence
  2. Individuals must report using marijuana at least 5 days a week and have a positive urine test for THC on the day of study entry.
  3. Individual must describe marijuana as their primary drug of abuse.
  4. Individuals must be capable of giving informed consent and capable of complying with study procedures.

Exclusion Criteria:

  1. Meets DSM-IV-TR criteria for schizophrenia, schizoaffective illness, psychotic disorder other than transient psychosis due to drug abuse, major depression, bipolar illness or psychiatric disorders (other than substance abuse) which require psychiatric intervention.
  2. Individuals who are medically unstable based on laboratory tests, electrocardiogram, medical history, physical examination that would make participation hazardous
  3. Individuals with liver enzyme function tests greater than three times normal
  4. Individuals with a history of seizure disorder
  5. Individuals with current suicidal risk.
  6. Individuals who are cognitively impaired
  7. Bradycardia (< 50 beats/minute), hypotension (sitting or standing BP < 90/50), or symptoms attributable to low BP (i.e. lightheadedness or dizziness on standing).
  8. Nursing mothers and pregnant women. Women of child bearing age will be included in the study provided that they are not pregnant, based on the results of a blood pregnancy test drawn at the time of screening. They must also agree to use a method of contraception with proven efficacy and agree not to become pregnant during the study. To confirm this, urine pregnancy tests will be repeated monthly. Women will be provided a full explanation of the potential dangers of pregnancy while on the study medication. If a woman becomes pregnant, the study medication will be discontinued.
  9. Individuals who are physiologically dependent on any other drugs (excluding nicotine) that would require a medical intervention
  10. Individuals with known sensitivity to dronabinol or lofexidine
  11. Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG or history of cardiac symptoms
  12. Individuals currently being treated with an alpha-2 agonist antihypertensive medication
  13. Individuals currently being prescribed a psychotropic medication (including sleep medication). However, medication for depression is allowed if stable for at least 1 month.
  14. Individuals who have a job that even mild intoxication would be hazardous (e.g., firefighter, bus driver)
  15. Individuals who are court-mandated to treatment.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020019

Contacts

Contact: Amy Mahony, MA(212) 740-7350mahonya@pi.cpmc.columbia.edu

Contact: Daniel J Brooks, MA(212) 740-3205brooksd@pi.cpmc.columbia.edu

 

Locations

United States, New York

New York State Psychiatric InstituteRecruiting

New York, New York, United States, 10032

Contact: Amy Mahony, M.A.    212-923-3031    mahonya@pi.cpmc.columbia.edu   

Contact: Elizabeth Martinez    (212) 923-3031    martinez@pi.cpmc.columbia.edu   

Principal Investigator: Frances R Levin, M.D.         

Sponsors and Collaborators

New York State Psychiatric Institute

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:Frances R Levin, M.D.Columbia University

  More Information
No publications provided 

Responsible Party:New York State Psychiatric Institute

ClinicalTrials.gov Identifier:NCT01020019     History of Changes

Other Study ID Numbers:#6015, P50DA009236-16, DPMC

Study First Received:November 24, 2009

Last Updated:October 29, 2013

Health Authority:United States: Food and Drug Administration


Keywords provided by New York State Psychiatric Institute:

Cannabis Dependence
Marijuana Dependence
Marinol
Lofexidine


Additional relevant MeSH terms:

Marijuana Abuse
Substance-Related Disorders
Mental Disorders
Tetrahydrocannabinol
Lofexidine
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antihypertensive Agents
Cardiovascular Agents
Narcotic Antagonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action


ClinicalTrials.gov processed this record on March 30, 2014