INTERVENTIONALCOMPLETEDNCT01323569

A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Abuse Potential of Sativex in Subjects With a History of Recreational Marijuana Use

This crossover study with six treatment sessions is to evaluate the abuse potential of three doses of Sativex as compared to Marinol and placebo, in subjects with a history of recreational marijuana use.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2023-04-10

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE1
Enrollment: 58 (ACTUAL)
Start date: 2008-02
Sponsor: Jazz Pharmaceuticals
Design: RANDOMIZED · CROSSOVER · BASIC SCIENCE
Locations: 1
Results record: Not present in registry snapshot

Subjects attended a two-session, randomized, double-blind, crossover qualification in which they received the positive control drug (Marinol 30 mg) and matching placebo 48 hours apart in a randomized fashion. To qualify, subjects must have discriminated between Marinol and placebo. Eligible subjects then went on to the main study divided into six treatment sessions each separated by 7-21 days. Serial pharmacodynamic evaluations were taken at each treatment session as well as occasional pharmacokinetic blood samples to verify proof of exposure. In addition, safety monitoring included regular assessments of vital signs, telemetry, 12-lead ECG, clinical laboratory tests and adverse events (AEs).

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

No governed compound link was found.

Medicines

MARINOL Marinol MARINOL SATIVEX

Interventions

What was registered

DRUG

Sativex

Sativex dose level 1: 10.8 mg THC/10 mg CBD (4 sprays) + 12 placebo sprays + 4 placebo capsules.

DRUG

Sativex

Sativex dose level 2: 21.6 mg THC/20 mg CBD (8 sprays) + 8 placebo sprays + 4 placebo capsules

DRUG

Sativex

Sativex dose level 3: 43.2 mg THC/40 mg CBD (16 sprays) + 4 placebo capsules

DRUG

Placebo

16 placebo sprays and 4 placebo capsules

DRUG

Marinol

Marinol dose level 1: 20 mg THC (2 marinol capsules) + 2 placebo capsules + 16 placebo sprays

DRUG

Marinol

Marinol dose level 2: 40 mg THC (4 marinol capsules) + 16 placebo sprays

Eligibility

Population and criteria

Sex: ALL
Minimum age: 19 Years
Maximum age: 45 Years
Healthy volunteers: Accepted

Inclusion criteria

Healthy male and female subjects, 19 to 45 years of age, inclusive.
Current recreational marijuana users, defined as the use of smoked marijuana, hashish, or oral THC, at least once a week for the 3 months prior to screening and, on at least one occasion, four times in a given week in the 3 months prior to screening.
Body mass index within the range of 19 to 30 kg/m2 inclusive and a minimum weight of at least 50 kg at screening.
Free of any clinically significant abnormality, assessed at screening, on the basis of medical history, vital signs, physical examination, 12-lead ECG, and clinical laboratory tests, including haematology, clinical chemistry, urinalysis, and serology, as judged by the investigator or designee.
A positive urine THC drug screen at screening and qualification, which was confirmed by quantitative analysis; the level must have been at least 50 ng of THC/mL.
A negative urine drug screen for cocaine, opiates, amphetamine, and benzodiazepines upon admission to the screening, qualification session, or treatment sessions. Subjects who had a positive urine drug screen upon presentation to a study visit could have been rescheduled for another session at the discretion of the investigator.
All female subjects were required to have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to the qualification session and to each drug treatment session.
Subjects with reproductive potential could be entered into the study if they had been using and were willing to continue to use two methods of contraception for the duration of the study. These methods included male condom for men in addition to an oral contraceptive, contraceptive implant or injection, intrauterine device, diaphragm, or a contraceptive sponge for women. Adequate protection, as defined above, had to have been used for at least 1 month prior to screening for all, with the exception of oral contraceptives, which should have been used for at least 3 months prior to screening. These methods had to be continually used for 30 days after the end of the study. Subjects that had been surgically sterilized (tubal ligation, hysterectomy, or vasectomy) or had been post-menopausal for at least 2 years (by history) were not considered to be of reproductive potential.
Subjects had to pass a qualification session.
Must have understood and provided written informed consent, prior to initiation of any protocol-specific procedures.

primary outcomes

primary measures

Comparison of Subjective Drug Value (SDV)(Balance of effects) between Marinol and Sativex

Time frame: Recorded at 6, 12 and 24 hours during each study arm

Mean difference in Mean peak effect (Emax) between: Marinol 20 mg vs Sativex 21.6 mg; Marinol 20 mg vs Sativex 43.2 mg; Marinol 40 mg vs Sativex 43.2 mg.

Comparison of Bipolar Drug Liking VAS (Balance of effects) between Marinol and Sativex

Time frame: Recorded at 12 and 24 hours during each study arm

Mean difference in Mean peak effect (Emax) between: Marinol 20 mg vs Sativex 21.6 mg; Marinol 20 mg vs Sativex 43.2 mg; Marinol 40 mg vs Sativex 43.2 mg.

Comparison of Addiction Research Centre Inventory (ARCI) MBG (Positive effects) between Marinol and Sativex

Time frame: Recorded at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours during each study arm

Mean difference in Mean peak effect (Emax) between: Marinol 20 mg vs Sativex 21.6 mg; Marinol 20 mg vs Sativex 43.2 mg; Marinol 40 mg vs Sativex 43.2 mg.

secondary outcomes

secondary measures

Comparison of Balance of Effects VASs between Marinol and Sativex

Time frame: Recorded at 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours during each study arm

Mean difference in Mean peak effect (Emax) between: Marinol 20 mg vs Sativex 21.6 mg; Marinol 20 mg vs Sativex 43.2 mg; Marinol 40 mg vs Sativex 43.2 mg. for each of Overall Drug Liking VAS, Take Drug Again VAS, Pleasant Mental state VAS, and Pleasant Physical state VAS.

Comparison of Positive Effects VASs between Marinol and Sativex

Time frame: Recorded at 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours during each study arm

Mean difference in Mean peak effect (Emax) between: Marinol 20 mg vs Sativex 21.6 mg; Marinol 20 mg vs Sativex 43.2 mg; Marinol 40 mg vs Sativex 43.2 mg; for each of Good effects VAS and High VAS.

Comparison of Cannabinoid Effects between Marinol and Sativex

Time frame: Recorded at 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours during each study arm

Mean difference in Mean peak effect (Emax) between: Marinol 20 mg vs Sativex 21.6 mg; Marinol 20 mg vs Sativex 43.2 mg; Marinol 40 mg vs Sativex 43.2 mg; for each of ARCI Marijuana, Stoned VAS, Mellow VAS, Clarity VAS, and Hungry VAS.

Comparison of Negative Effects Scores between Marinol and Sativex

Time frame: Recordedat 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours during each study arm

Mean difference in Mean peak effect (Emax) between: Marinol 20 mg vs Sativex 21.6 mg; Marinol 20 mg vs Sativex 43.2 mg; Marinol 40 mg vs Sativex 43.2 mg; for each of ARCI Lysergic Acid Diethylamide, Bad Effects VAS, Nausea VAS, Feeling Sick VAS, and Room Spinning VAS.

Comparison of Other Effects Scores between Marinol and Sativex

Time frame: Recorded pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours during each study arm

Mean difference in Mean peak effect (Emax) between: Marinol 20 mg vs Sativex 21.6 mg; Marinol 20 mg vs Sativex 43.2 mg; Marinol 40 mg vs Sativex 43.2 mg; for each of: Any effects VAS, Dizziness VAS, ARCI Pentobarbital-Chlorpromazine-Alcohol Group, Drowsiness VAS, ARCI Benzedrine Group, and ARCI Amphetamine, Drug similarity VASs, Choice Reaction Time, Divided Attention, Sternberg short-term memory tests.

Area under the concentration-time curve from 0 to 8.5 hours post-dose for plasma THC, CBD, and 11-hydroxy-THC.

Publications

Locally readable linked articles

No exact PMID-linked public article is currently readable locally.

Snapshot provenance

Snapshot: 98b7a1f4-fa10-44b8-ab4d-e8f56edf31d3
Retrieved: 11/09/2026, 14:16:43
SHA-256: 78bc7deb0e1864153fb44148f676d912e1e5fd253224dd96c9a981553293dd2d

A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Abuse Potential of Sativex in Subjects With a History of Recreational Marijuana Use

Protocol only - no registry results posted

Study at a glance

Related local records

Conditions

Cannabinoids and active compounds

Medicines

What was registered

Sativex

Sativex

Sativex

Placebo

Marinol

Marinol

Population and criteria

Inclusion criteria

primary measures

Comparison of Subjective Drug Value (SDV)(Balance of effects) between Marinol and Sativex

Comparison of Bipolar Drug Liking VAS (Balance of effects) between Marinol and Sativex

Comparison of Addiction Research Centre Inventory (ARCI) MBG (Positive effects) between Marinol and Sativex

secondary measures

Comparison of Balance of Effects VASs between Marinol and Sativex

Comparison of Positive Effects VASs between Marinol and Sativex

Comparison of Cannabinoid Effects between Marinol and Sativex

Comparison of Negative Effects Scores between Marinol and Sativex

Comparison of Other Effects Scores between Marinol and Sativex

Area under the concentration-time curve from 0 to 8.5 hours post-dose for plasma THC, CBD, and 11-hydroxy-THC.

Locally readable linked articles

Exclusion criteria

Adverse Events