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Responses to Marijuana-Related Cues Versus Neutral Cues in Adults Taking Tetrahydrocannabinol (THC) - 2
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), July 2008
Sponsors and Collaborators: National Institute on Drug Abuse (NIDA)
Wayne State University
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00218504
  Purpose

The majority of past research on marijuana treatment has targeted the alleviation of withdrawal symptoms. Minimal focus has been placed on how altering craving effects may play a role in treating marijuana addiction. Treatment with tetrahydrocannabinol (THC), the main ingredient in marijuana responsible for its reinforcing effects, may decrease marijuana cravings. The purpose of this study is to evaluate the effect of THC pre-treatment on responses to marijuana-related cues versus non marijuana-related cues in individuals addicted to marijuana.


Condition Intervention Phase
Marijuana Abuse
Drug: Tetrahydrocannabinol
Phase I

MedlinePlus related topics: Marijuana
Drug Information available for: Tetrahydrocannabinol Cannabis GW-1000
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Cue Reactivity Model for Assessing Pharmacologic Intervention in Treatment of Cannabis Use Disorders (Study 2)

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Marijuana craving [ Time Frame: Measured throughout the cue exposure session ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 20
Study Start Date: December 2005
Intervention Details:
    Drug: Tetrahydrocannabinol
    Participants will be randomly assigned to receive an oral dose of 10 mg of THC, 20 mg of THC, or placebo.
Detailed Description:

Marijuana is the most commonly used illegal drug in the United States; more than 2 million Americans either abuse or are dependent on the drug. Therefore, there is a clear need for treatment options. Past research on marijuana treatments has focused on alleviating withdrawal symptoms. Minimal focus has been placed on how altering craving effects may play a role in treating marijuana addiction. Treatment with THC, a component of marijuana that causes the "high" sensation, may reduce marijuana cravings. This study will evaluate the subjective and physiological responses to marijuana-related cues versus non marijuana-related cues in marijuana users who have been pre-treated with THC.

Participants will attend three 6-hour sessions, each separated by at least 7 days. Prior to each testing session, participants will spend the night at the Psychiatric and Addiction Research Center at Detroit Receiving Hospital in order to ensure no alcohol or drug use during the 12 hours preceding the session. Participants will be randomly assigned to receive an oral dose of 10 mg of THC, 20 mg of THC, or placebo. They will then undergo a cue exposure test during which they will be shown a nature video and will be asked to handle and smell various items; these will act as neutral, non marijuana-related cues. Next, the participants will watch a video of individuals smoking marijuana and will be asked to handle and smell marijuana-related items; these will act as the marijuana-related cues. Heart rate and skin temperature will be monitored continuously throughout each session with the use of electrodes and a skin thermometer. Prior to and after the cue exposure sessions blood pressure will be measured and questionnaires will be administered to assess drug cravings as well as related mood states. Prior to leaving the clinical center, the participants' vital signs will be evaluated to ensure that any cue-related physiological changes have returned to normal. Following the end of the study session, participants will have the option of talking to a clinician experienced in dealing with drug cravings.

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Marijuana dependent volunteers.

Criteria

Inclusion Criteria:

  • Meets DSM-IV diagnosis criteria for marijuana dependence
  • Able to read and write in English
  • Positive urine test for marijuana
  • If female, must be willing to use contraception throughout the study

Exclusion Criteria:

  • Meets DSM-IV diagnosis criteria for a psychiatric illness
  • History of a psychotic disorder
  • Seeking treatment for marijuana dependence
  • Neurologic disease, including structural brain abnormalities (e.g., neoplasms), stroke, seizures, infectious disease, head trauma resulting in unconsciousness, or evidence of neurologic illness resulting from HIV/AIDS
  • Cardiovascular disease, including edema, chest pain or palpitations after exertion or drug use, myocardial infarction (heart attack), systolic blood pressure greater than 160 mm Hg or less than 95 mm Hg, or diastolic blood pressure greater than 95 mm Hg
  • Pulmonary disease, including apnea, cor pulmonale, tuberculosis, dyspnea, orthopnea, or tachypnea
  • Systemic disease, including endocrinopathies, kidney or liver failure, hypothyroidism, adrenocortical insufficiency, or autoimmune disease involving the central nervous system
  • Currently dependent on any drug other than marijuana or nicotine
  • Cognitively impaired
  • Pregnant or breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00218504

Contacts
Contact: Ken Bates 1-888-457-3744 kbates@med.wayne.edu

Locations
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48207
Contact: Leslie H. Lundahl     313-993-1374     llundahl@med.wayne.edu    
Sponsors and Collaborators
Wayne State University
Investigators
Principal Investigator: Leslie H. Lundahl Wayne State University
  More Information

Responsible Party: Wayne State University ( Leslie Lundahl, PhD )
Study ID Numbers: NIDA-19236-2, R21-19236-2, DPMC
Study First Received: September 16, 2005
Last Updated: July 21, 2008
ClinicalTrials.gov Identifier: NCT00218504  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Tetrahydrocannabinol
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin
Marijuana Abuse

Additional relevant MeSH terms:
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Hallucinogens
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009